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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Micro Therapeutics Inc,: Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

Agency Publication Date: September 3, 2021
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Affected Products

Product: Pipeline Flex Embolization Device

Product/REF/UDI: PED-250-10 PIPELINE FLEX 2.50MM X 10MM PED-250-10 00847536014343 Lot Numbers: A815698 A835648 A837027 A837028 A856681 A867213 A877526 A879720 A885865 A887304 A889034 A894160 A898559 A910394 A911797 A915537 Product/REF/UDI: PED-250-12 PIPELINE FLEX 2.50MM X 12MM PED-250-12 00847536014374 A813321 A819204 A822948 A848725 A876747 A879721 A887306 A887308 A887311 A887311 A887314 A887314 A894161 A894162 A894163 A904254 A908288 B005860 B017059 Product/REF/UDI: PED-250-14 PIPELINE FLEX 2.50MM X 14MM PED-250-14 00847536014404 Lot Numbers: A813323 A822948 A839880 A854063 A859756 A879723 A879724 A889035 A889037 A902102 A906073 A914143 A915539 Product/REF/UDI: PED-250-16 PIPELINE FLEX 2.50MM X 16MM PED-250-16 00847536014435 Lot Numbers: A822949 A829045 A843379 A882136 A887316 A889039 A894609 A909355 B005846 Product/REF/UDI: PED-250-18 PIPELINE FLEX 2.50MM X 18MM PED-250-18 00847536014466 Lot Numbers: A867848 A877526 A877527 A877532 A879725 A887317 A910395 B007408 Product/REF/UDI: PED-250-20 PIPELINE FLEX 2.50MM X 20MM PED-250-20 00847536014497 Lot Numbers: A867214 A877533 A885866 A885867 A887318 Product/REF/UDI: PED-275-10 PIPELINE FLEX 2.75MM X 10MM PED-275-10 00847536014527 Lot Numbers: A854607 A867215 A900753 A912447 B002744 Product/REF/UDI: PED-275-12 PIPELINE FLEX 2.75MM X 12MM PED-275-12 00847536014558 Lot Numbers: A822950 A864485 A866005 A873187 A873201 A885868 A885869 A906074 A909356 Product/REF/UDI: PED-275-14 PIPELINE FLEX 2.75MM X 14MM PED-275-14 00847536014589 Lot Numbers: A812097 A822951 A861761 A873187 A873201 A873204 A873205 A874035 A874035 A883589 A885870 A885871 A885872 A906076 A906725 Product/REF/UDI: PED-275-16 PIPELINE FLEX 2.75MM X 16MM PED-275-16 00847536014619 Lot Numbers: A813324 A877534 A883590 A894164 A894611 B005862 Product/REF/UDI: PED-275-18 PIPELINE FLEX 2.75MM X 18MM PED-275-18 00847536014640 Lot Numbers: A823540 A876748 A882137 A894613 Product/REF/UDI: PED-275-20 PIPELINE FLEX 2.75MM X 20MM PED-275-20 00847536014671 Lot Numbers: A864487 A866006 A896158 A896159 A900754 Product/REF/UDI: PED-300-10 PIPELINE FLEX 3.00MM X 10MM PED-300-10 00847536014701 Lot Numbers: A823542 A870630 A878414 A879726 A894613 A910395 Product/REF/UDI: PED-300-12 PIPELINE FLEX 3.00MM X 12MM PED-300-12 00847536014732 Lot Numbers: A839881 A848726 A863674 A863675 A865228 A866008 A896160 A902103 A903567 A911798 Product/REF/UDI: PED-300-14 PIPELINE FLEX 3.00MM X 14MM PED-300-14 00847536014763 Lot Numbers: 00847536014763 00847536014763 00847536014763 00847536014763 00847536014763 00847536014763 00847536014763 00847536014763 00847536014763 Product/REF/UDI: PED-300-16 PIPELINE FLEX 3.00MM X 16MM PED-300-16 00847536014794 Lot Numbers: A829045 A850778 A852544 A865229 A866009 A896161 A902104 A902106 A906077 B008202 Product/REF/UDI: PED-300-18 PIPELINE FLEX 3.00MM X 18MM PED-300-18 00847536014824 Lot Numbers: A835649 A850780 A852545 A852546 A867713 A902106 A902107 Product/REF/UDI: PED-300-20 PIPELINE FLEX 3.00MM X 20MM PED-300-20 00847536014855 Lot Numbers: A813325 A819205 A823544 A870631 A876749 A878414 A879731 A882138 A895293 A911799 B002749 B005863 Product/REF/UDI: PED-300-25 PIPELINE FLEX 3.00MM X 25MM PED-300-25 00847536014886 Lot Numbers: A813325 A865229 A866010 A874036 A909357 A910396 Product/REF/UDI: PED-300-30 PIPELINE FLEX 3.00MM X 30MM PED-300-30 00847536014916 Lot Numbers: A843381 A859757 A861763 A873188 A873189 A873190 Product/REF/UDI: PED-300-35 PIPELINE FLEX 3.00MM X 35MM PED-300-35 00847536014947 Lot Numbers: A843385 A848727 A879732 A883591 Product/REF/UDI: PED-325-10 PIPELINE FLEX 3.25MM X 10MM PED-325-10 00847536014978 Lot Numbers: A813326 A894165 A900262 A910397 Product/REF/UDI: PED-325-12 PIPELINE FLEX 3.25MM X 12MM PED-325-12 00847536015005 Lot Numbers: A823545 A829047 A843387 A843389 A879733 A879734 A887319 A895294 A900263 A909358 A909360 B002757 B008203 Product/REF/UDI: PED-325-14 PIPELINE FLEX 3.25MM X 14MM PED-325-14 00847536015036 Lot Numbers: A823546 A835650 A835651 A837029 A837030 A839886 A887320 A894393 A900265 A911800 B008204 B008206 Product/REF/UDI: PED-325-16 PIPELINE FLEX 3.25MM X 16MM PED-325-16 00847536015067 Lot Numbers: A826928 A843391 A843393 A858345 A874039 A882139 A882141 A887320 A900756 B008207 Product/REF/UDI: PED-325-18 PIPELINE FLEX 3.25MM X 18MM PED-325-18 00847536015098 Lot Numbers: A813327 A819208 A823548 A823549 A879735 A880355 A895295 A899369 Product/REF/UDI: PED-325-20 PIPELINE FLEX 3.25MM X 20MM PED-325-20 00847536015128 Lot Numbers: A823550 A848744 A861764 A868568 A873191 A874039 A880355 A882141 A909361 A910398 A910918 B005864 Product/REF/UDI: PED-325-25 PIPELINE FLEX 3.25MM X 25MM PED-325-25 00847536015159 Lot Numbers: A813329 A815698 A819209 A852547 A880357 A898562 A899369 Product/REF/UDI: PED-325-30 PIPELINE FLEX 3.25MM X 30MM PED-325-30 00847536015180 Lot Numbers: A839887 A854822 A859758 Product/REF/UDI: PED-325-35 PIPELINE FLEX 3.25MM X 35MM PED-325-35 00847536015210 Lot Numbers: A829048 A850781 A852548 A865230 A866010 A899370 A909361 A912449 Product/REF/UDI: PED-350-10 PIPELINE FLEX 3.50MM X 10MM PED-350-10 00847536015241 Lot Numbers: A812119 A819062 A889041 A894394 A894396 B008208 Product/REF/UDI: PED-350-12 PIPELINE FLEX 3.50MM X 12MM PED-350-12 00847536015272 Lot Numbers: A817117 A823551 A826930 A843396 A844327 A859759 A871937 A885873 A894397 A894398 A902107 A903540 A908291 A911801 A912451 B005852 B008215 Product/REF/UDI: PED-350-14 PIPELINE FLEX 3.50MM X 14MM PED-350-14 00847536015296 Lot Numbers: A813907 A823553 A829744 A844327 A844328 A844329 A844330 A856682 A861765 A890031 A894400 A894401 A898564 A899372 A902751 A906079 A906734 A909361 A910919 A910920 A911802 A911803 A914208 A914212 Product/REF/UDI: PED-350-16 PIPELINE FLEX 3.50MM X 16MM PED-350-16 00847536015333 Lot Numbers: A829745 A834388 A839889 A844331 A844333 A844335 A844336 A856683 A890034 A894402 A894404 A899373 A900757 A902753 A914214 Product/REF/UDI: PED-350-18 PIPELINE FLEX 3.50MM X 18MM PED-350-18 00847536015364 Lot Numbers: A815699 A837024 A844759 A850788 A859760 A859761 A861766 A871938 A874042 A883593 A884540 A908292 A914206 A914804 Product/REF/UDI: PED-350-20 PIPELINE FLEX 3.50MM X 20MM PED-350-20 00847536015395 Lot Numbers: A813907 A815702 A816329 A817119 A820989 A823553 A844760 A844761 A890035 A890036 A890037 A890038 A896162 A899375 A899376 A900758 A909362 A909363 A913162 A914075 A914076 A914077 A914141 A914142 A914144 A914805 B005837 B005865 B007373 Product/REF/UDI: PED-350-25 PIPELINE FLEX 3.50MM X 25MM PED-350-25 00847536015425 Lot Numbers: A810945 A817119 A837026 A850789 A850790 A861767 A865231 A873191 A874045 A880359 A912440 B005838 Product/REF/UDI: PED-350-30 PIPELINE FLEX 3.50MM X 30MM PED-350-30 00847536015456 Lot Numbers: A817119 A850791 A856684 A865232 A866011 A874046 A904246 Product/REF/UDI: PED-350-35 PIPELINE FLEX 3.50MM X 35MM PED-350-35 00847536015487 Lot Numbers: A823553 A861768 A895296 A900759 Product/REF/UDI: PED-375-10 PIPELINE FLEX 3.75MM X 10MM PED-375-10 00847536015517 Lot Numbers: A823554 A869097 A877514 A880359 A900253 A912441 Product/REF/UDI: PED-375-12 PIPELINE FLEX 3.75MM X 12MM PED-375-12 00847536015548 Lot Numbers: A823555 A844762 A844763 A852549 A861768 A877516 A880361 A885874 A885877 A910922 B008216 Product/REF/UDI: PED-375-14 PIPELINE FLEX 3.75MM X 14MM PED-375-14 00847536015579 Lot Numbers: A811477 A813908 A819102 A821009 A830782 A841067 A865233 A866011 A870632 A871941 A874049 A877517 A878417 A878418 A878419 A882143 A882146 A890039 A894405 A895302 A896163 A908295 A913140 B008217 Product/REF/UDI: PED-375-16 PIPELINE FLEX 3.75MM X 16MM PED-375-16 00847536015609 Lot Numbers: A811477 A817119 A821010 A826931 A826932 A841068 A852550 A854823 A867714 A869098 A877518 A878420 A880362 A880363 A882147 A885880 A890041 A894406 A896936 A909370 A910923 Product/REF/UDI: PED-375-18 PIPELINE FLEX 3.75MM X 18MM PED-375-18 00847536015623 Lot Numbers: A813909 A832014 A838062 A844763 A848745 A852551 A859761 A861769 A884541 A887321 A896937 A902089 B005867 Product/REF/UDI: PED-375-20 PIPELINE FLEX 3.75MM X 20MM PED-375-20 00847536015661 Lot Numbers: A832014 A835652 A835653 A837026 A848746 A850792 A850793 A850795 A850796 A851427 A852551 A863676 A880365 A887928 A897373 A902755 B007374 Product/REF/UDI: PED-375-25 PIPELINE FLEX 3.75MM X 25MM PED-375-25 00847536015692 Lot Numbers: A829746 A844763 A844764 A852552 A856685 A861771 A874050 A897375 A900266 A908296 B007366 Product/REF/UDI: PED-375-30 PIPELINE FLEX 3.75MM X 30MM PED-375-30 00847536015722 Lot Numbers: A841069 A852553 A856686 A868571 A906733 A907482 Product/REF/UDI: PED-375-35 PIPELINE FLEX 3.75MM X 35MM PED-375-35 00847536015753 Lot Numbers: A865233 A866012 A886638 A894597 A904870 B007367 Product/REF/UDI: PED-400-10 PIPELINE FLEX 4.00MM X 10MM PED-400-10 00847536015784 Lot Numbers: A823556 A838063 A841072 A878840 A887929 A897377 A906736 A909371 Product/REF/UDI: PED-400-12 PIPELINE FLEX 4.00MM X 12MM PED-400-12 00847536015807 Lot Numbers: A813912 A813912 A817119 A823559 A823559 A830782 A838064 A841072 A854824 A869101 A877519 A877520 A878842 A878844 A878845 A880366 A880367 A880367 A880368 A882796 A882797 A887930 A887931 A887932 A906737 A907483 A908626 A910924 A914210 Product/REF/UDI: PED-400-14 PIPELINE FLEX 4.00MM X 14MM PED-400-14 00847536015845 Lot Numbers: A817119 A823560 A826932 A830783 A844765 A844766 A844766 A856687 A859762 A859763 A859764 A869102 A869105 A871380 A871943 A878846 A878848 A880369 A882798 A882799 A882800 A886640 A887933 A906728 A910924 A913143 A914806 Product/REF/UDI: PED-400-16 PIPELINE FLEX 4.00MM X 16MM PED-400-16 00847536015876 Lot Numbers: A813912 A817119 A823561 A824249 A826933 A830785 A848747 A854825 A854826 A856742 A856743 A859765 A867715 A867716 A868572 A871943 A871943 A877521 A878849 A880370 A882801 A882802 A887934 A887937 A896938 A914207 B008219 Product/REF/UDI: PED-400-18 PIPELINE FLEX 4.00MM X 18MM PED-400-18 00847536015906 Lot Numbers: A821011 A824251 A844767 A845199 A845201 A859765 A862900 A862901 A871944 A882804 A882805 A886640 A887938 A895303 A897378 A902090 A902091 A906054 A907484 A913144 A914808 A914809 A914810 A914811 B005839 Product/REF/UDI: PED-400-20 PIPELINE FLEX 4.00MM X 20MM PED-400-20 00847536015937 Lot Numbers: A813913 A816330 A817119 A821012 A835655 A837027 A845202 A845204 A845205 A845206 A848749 A848749 A859164 A859165 A859766 A859767 A859768 A862902 A871382 A871944 A874053 A882806 A884542 A895304 A902092 A904234 A904255 A909371 A909372 A909372 A909373 A913145 A914812 A914814 A917152 B005848 B005849 B007407 Product/REF/UDI: PED-400-25 PIPELINE FLEX 4.00MM X 25MM PED-400-25 00847536015968 Lot Numbers: A817119 A829747 A838065 A838084 A841073 A841074 A841075 A854827 A856744 A867717 A887940 A887941 A896938 A896941 B007375 Product/REF/UDI: PED-400-30 PIPELINE FLEX 4.00MM X 30MM PED-400-30 00847536015999 Lot Numbers: A817123 A852554 A854828 A859166 A859769 A868573 A869087 A874057 A817126 A856745 A859770 A867718 A869897 A874059 A886640 B007376 Product/REF/UDI: PED-425-10 PIPELINE FLEX 4.25MM X 10MM PED-425-10 00847536016057 Lot Numbers: A874062 A886642 A910925 Product/REF/UDI: PED-425-12 PIPELINE FLEX 4.25MM X 12MM PED-425-12 00847536016071 Lot Numbers: A816330 A817130 A826934 A827586 A829748 A845207 A845208 A848750 A859771 A859772 A862904 A874064 A890605 A900254 A903565 A908627 A912442 A917154 Product/REF/UDI: PED-425-14 PIPELINE FLEX 4.25MM X 14MM PED-425-14 00847536016118 Lot Numbers: A816330 A827587 A834389 A845209 A848751 A852555 A859773 A863677 A875013 A880371 A883575 A883576 A883576 A883577 A884543 A890606 A895305 A895306 A895307 A896942 A906055 A906068 A907490 A909373 A914815 A914816 A914817 B005853 B013889 Product/REF/UDI: PED-425-16 PIPELINE FLEX 4.25MM X 16MM PED-425-16 00847536016149 Lot Numbers: A813915 A827587 A835656 A845210 A852556 A856746 A863678 A865234 A866014 A867719 A867721 A869898 A875015 A880372 A880373 A883578 A884544 A890609 A890612 A894599 A895308 A902756 A904255 A906729 Product/REF/UDI: PED-425-18 PIPELINE FLEX 4.25MM X 18MM PED-425-18 00847536016170 Lot Numbers: A816330 A821013 A824252 A841076 A854829 A859773 A862905 A888378 A888379 A896944 A896945 A898564 A900254 A906069 A908628 Product/REF/UDI: PED-425-20 PIPELINE FLEX 4.25MM X 20MM PED-425-20 00847536016200 Lot Numbers: A813915 A816334 A817751 A818291 A818292 A819105 A821014 A841077 A845211 A849265 A849265 A854832 A859774 A859775 A859776 A867849 A871384 A875017 A888380 A896946 A899357 A899360 A900255 A900256 A902758 A902759 A902760 A902761 A904243 A909374 Product/REF/UDI: PED-425-25 PIPELINE FLEX 4.25MM X 25MM PED-425-25 00847536016231 Lot Numbers: A817753 A818295 A827589 A835657 A859776 A862906 A869078 A869079 A871386 A873192 A875022 A875030 A881403 A883579 A904871 B007377 Product/REF/UDI: PED-425-30 PIPELINE FLEX 4.25MM X 30MM PED-425-30 00847536016262 Lot Numbers: A816335 A829750 A841081 A845212 A849266 A859167 A859777 A862907 A873192 A875033 A881405 A884546 A906057 Product/REF/UDI: PED-425-35 PIPELINE FLEX 4.25MM X 35MM PED-425-35 00847536016293 Lot Numbers: A829751 A838085 A845213 A854833 A856747 A859778 A896947 A908634 A909375 A909377 A909378 B007378 Product/REF/UDI: PED-450-10 PIPELINE FLEX 4.50MM X 10MM PED-450-10 00847536016323 Lot Numbers: A835658 A852556 Product/REF/UDI: PED-450-12 PIPELINE FLEX 4.50MM X 12MM PED-450-12 00847536016354 Lot Numbers: A817754 A827591 A835659 A863679 A871947 A881406 A881406 A890613 A895309 A903545 A910385 A910387 A915508 Product/REF/UDI: PED-450-14 PIPELINE FLEX 4.50MM X 14MM PED-450-14 00847536016385 Lot Numbers: A813916 A821016 A824252 A824253 A841084 A854834 A859778 A863680 A869081 A871949 A878850 A881407 A883581 A884549 A890614 A890615 A895310 A896948 A900258 A902762 A902764 A906730 A907491 A910389 A915540 Product/REF/UDI: PED-450-16 PIPELINE FLEX 4.50MM X 16MM PED-450-16 00847536016415 Lot Numbers: A813917 A817756 A821017 A824253 A829751 A835660 A838086 A846023 A846024 A846024 A846025 A851428 A852557 A862908 A867722 A878850 A881408 A883582 A884549 A888381 A890619 A895312 A896948 A900736 A902093 A902764 A903560 A906726 A906730 A906735 A907480 A908629 A910390 A910391 A910926 A910927 A912443 A912444 A912445 A913148 A913149 A913155 A913155 A913156 A913157 A915516 A915541 Product/REF/UDI: PED-450-18 PIPELINE FLEX 4.50MM X 18MM PED-450-18 00847536016446 A813920 A813921 A821018 A824257 A841086 A852711 A859779 A862909 A863681 A871949 A875034 A875035 A883583 A884551 A886644 A906062 A906063 A908629 A910392 A915518 A915542 B007400 B007401 B015360 Product/REF/UDI: PED-450-20 PIPELINE FLEX 4.50MM X 20MM PED-450-20 00847536016477 Lot Numbers: A815062 A817758 A821019 A821020 A824258 A835661 A841088 A851429 A855375 A856748 A863682 A863683 A867723 A867838 A869899 A871949 A878851 A881409 A883585 A884552 A884552 A884576 A888383 A906731 A910928 A915520 A916289 A917155 A917157 A917159 Product/REF/UDI: PED-450-25 PIPELINE FLEX 4.50MM X 25MM PED-450-25 00847536016507 Lot Numbers: A817759 A821029 A832005 A835662 A835663 A846025 A846027 A846028 A846030 A852712 A852713 A862910 A881409 A886644 A886647 A897379 A908631 A915521 A916290 B007368 Product/REF/UDI: PED-450-30 PIPELINE FLEX 4.50MM X 30MM PED-450-30 00847536016538 Lot Numbers: A815063 A819110 A846032 A849267 A851431 A855377 A855378 A856749 A898544 A898545 A900739 A902094 Product/REF/UDI: PED-450-35 PIPELINE FLEX 4.50MM X 35MM PED-450-35 00847536016569 Lot Numbers: A815064 A841090 A856750 A856751 A856752 A862911 A864456 A869900 A871390 A871951 A873193 A875035 A875036 A875036 A884579 A904256 A906064 A910929 A913158 B005850 B007369 B007402 B007403 Product/REF/UDI: PED-475-10 PIPELINE FLEX 4.75MM X 10MM PED-475-10 00847536016590 Lot Numbers: A817761 A827591 A903544 Product/REF/UDI: PED-475-12 PIPELINE FLEX 4.75MM X 12MM PED-475-12 00847536016620 Lot Numbers: A818296 A827592 A865235 A866014 A884580 A890623 A900260 B016955 Product/REF/UDI: PED-475-14 PIPELINE FLEX 4.75MM X 14MM PED-475-14 00847536016651 Lot Numbers: A824259 A851432 A856753 A869901 A875037 A877523 A881410 A881412 A883586 A890625 A907481 A914209 Product/REF/UDI: PED-475-16 PIPELINE FLEX 4.75MM X 16MM PED-475-16 00847536016682 A816338 A818297 A827593 A827594 A833120 A838089 A846033 A849269 A881414 A890626 A890627 A895312 A895313 A895314 A895314 A906053 A910393 A910930 A911793 A911794 A915523 A915524 B016957 Product/REF/UDI: PED-475-18 PIPELINE FLEX 4.75MM X 18MM PED-475-18 00847536016712 Lot Numbers: A815065 A821504 A824260 A868552 A869902 A877524 A878853 A878853 A881414 A881415 A881415 A883587 A886649 A886650 A886651 A895315 A896153 A896154 A903561 A913160 B016960 B016962 Product/REF/UDI: PED-475-20 PIPELINE FLEX 4.75MM X 20MM PED-475-20 00847536016743 Lot Numbers: A821505 A824262 A824263 A824264 A841091 A859168 A859169 A864456 A871391 A871391 A871951 A876745 A876746 A881416 A881417 A902095 A908633 A916291 Product/REF/UDI: PED-475-25 PIPELINE FLEX 4.75MM X 25MM PED-475-25 00847536016774 Lot Numbers: A815066 A824264 A838092 A851433 A852714 A852714 A852715 A856754 A867839 A867840 A869087 A871392 A907496 A907497 A911795 A911796 A916292 Product/REF/UDI: PED-475-30 PIPELINE FLEX 4.75MM X 30MM PED-475-30 00847536016804 Lot Numbers: A815067 A824266 A825688 A838095 A838097 A838100 A851434 A852716 A852717 A855382 A869903 A871392 A907498 B007404 B007405 Product/REF/UDI: PED-475-35 PIPELINE FLEX 4.75MM X 35MM PED-475-35 00847536016835 Lot Numbers: A838102 A841092 A852718 A852718 A856755 A867841 A869082 A869088 A869904 A907499 A907500 A908635 Product/REF/UDI: PED-500-10 PIPELINE FLEX 5.00MM X 10MM PED-500-10 00847536016866 Lot Numbers: A817762 A827595 A902767 A903541 A908636 Product/REF/UDI: PED-500-12 PIPELINE FLEX 5.00MM X 12MM PED-500-12 00847536016897 Lot Numbers: A825689 A825690 A838104 A841093 A855383 A897345 A900740 A902767 A903543 Product/REF/UDI: PED-500-14 PIPELINE FLEX 5.00MM X 14MM PED-500-14 00847536019645 Lot Numbers: A815071 A825695 A825696 A842684 A859174 A861601 A867843 A869905 A869906 A871393 A871952 A906080 A909350 A917160 Product/REF/UDI: PED-500-16 PIPELINE FLEX 5.00MM X 16MM PED-500-16 00847536019669 Lot Numbers: A812724 A815071 A821507 A821508 A825697 A846035 A849270 A859177 A862916 A862917 A864462 A876740 A876741 A876742 A876743 A884585 A886652 A906066 A906067 A906070 A906728 A917837 B005840 B016964 B016966 Product/REF/UDI: PED-500-18 PIPELINE FLEX 5.00MM X 18MM PED-500-18 00847536019690 Lot Numbers: A825698 A833121 A846036 A846036 A861602 A869907 A876744 A878854 A881418 A884589 A886653 A886654 A886655 A894600 A894600 A917839 B017057 B017058 Product/REF/UDI: PED-500-20 PIPELINE FLEX 5.00MM X 20MM PED-500-20 00847536019720 Lot Numbers: A815073 A816341 A825699 A825700 A830302 A832006 A833122 A833123 A835664 A846037 A846038 A846039 A846919 A846920 A849271 A861603 A861603 A861604 A871953 A871954 A881419 A886656 A887300 A887301 A889026 A889027 A890628 A909351 A909353 A909354 A915529 B007371 Product/REF/UDI: PED-500-25 PIPELINE FLEX 5.00MM X 25MM PED-500-25 00847536019751 Lot Numbers: A815074 A816341 A832007 A836543 A838105 A842687 A846922 A851436 A852252 A855386 A864463 A864463 A867844 A887302 A887303 A890629 A894601 A894602 A902767 A902772 A903537 A906724 A918056 A918057 A918058 B007406 Product/REF/UDI: PED-500-30 PIPELINE FLEX 5.00MM X 30MM PED-500-30 00847536019782 Lot Numbers: A821511 A826269 A826272 A842688 A842689 A855387 A855388 A855389 A861605 A862917 A867845 A869082 A897348 A903538 A918061 B007372 Product/REF/UDI: PED-500-35 PIPELINE FLEX 5.00MM X 35MM PED-500-35 00847536016903 Lot Numbers: A815068 A815069 A817763 A821506 A825691 A825692 A825693 A846034 A849270 A855384 A859171 A859172 A859780 A861600 A861601 A862912 A862914 A864457 A864459 A864460 A871952 A873193 A873194 A875039 A875042 A875048 A875051 A875056 A875062 A876738 A877525 A883588 A884581 A884583 A886652 A889026 A897347 A904252 A904257 A906065 A906071 A906072 A906727 A915527 B005851 B005855 B005859 B007370 Product/REF/UDI:

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Product: EV3 Pipeline Flex Embolization Device with Flex Shield Technology

Product/REF/UDI: PED2-250-10 PIPELINE FLEX SHIELD PED2-250-10 00847536002029 Lot Numbers: A816342 A827596 A834390 A849720 Product/REF/UDI: PED2-250-14 PIPELINE FLEX SHIELD PED2-250-14 00847536002043 Lot Numbers: A812725 A832008 A833123 A846924 Product/REF/UDI: PED2-250-16 PIPELINE FLEX SHIELD PED2-250-16 00847536002050 Lot Numbers: A816342 A826273 A827599 A832010 A842690 A846927 Product/REF/UDI: PED2-250-20 PIPELINE FLEX SHIELD PED2-250-20 00847536002074 Lot Numbers: A810946 A816343 A816343 A819116 Product/REF/UDI: PED2-275-12 PIPELINE FLEX SHIELD PED2-275-12 00847536002098 Lot Number: A916293 Product/REF/UDI: PED2-275-14 PIPELINE FLEX SHIELD PED2-275-14 00847536002104 Lot Numbers: A830303 A830304 A846930 A846931 Product/REF/UDI: PED2-275-16 PIPELINE FLEX SHIELD PED2-275-16 00847536002111 Lot Numbers: A819135 A846932 A855391 A859750 A869908 A871955 A873194 Product/REF/UDI: PED2-275-18 PIPELINE FLEX SHIELD PED2-275-18 00847536002128 Lot Numbers: A810946 A821512 A836546 A849721 Product/REF/UDI: PED2-275-20 PIPELINE FLEX SHIELD PED2-275-20 00847536002135 Lot Numbers: A827600 A842691 Product/REF/UDI: PED2-300-10 PIPELINE FLEX SHIELD PED2-300-10 00847536002142 Lot Numbers: A833123 A836549 Product/REF/UDI: PED2-300-12 PIPELINE FLEX SHIELD PED2-300-12 00847536002159 Lot Number: A821514 Product/REF/UDI: PED2-300-14 PIPELINE FLEX SHIELD PED2-300-14 00847536002166 Lot Numbers: A818298 A916294 Product/REF/UDI: PED2-300-16 PIPELINE FLEX SHIELD PED2-300-16 00847536002173 Lot Numbers: A826275 A830766 A834391 A846933 Product/REF/UDI: PED2-300-18 PIPELINE FLEX SHIELD PED2-300-18 00847536002180 Lot Numbers: A818299 A827602 A836550 A842691 A847555 Product/REF/UDI: PED2-300-20 PIPELINE FLEX SHIELD PED2-300-20 00847536002197 Lot Number: A916295 Product/REF/UDI: PED2-300-25 PIPELINE FLEX SHIELD PED2-300-25 00847536002685 Lot Numbers: A818459 A826923 A829033 A848678 Product/REF/UDI: PED2-300-30 PIPELINE FLEX SHIELD PED2-300-30 00847536002692 Lot Numbers: A829034 A848679 Product/REF/UDI: PED2-300-35 PIPELINE FLEX SHIELD PED2-300-35 00847536002708 Lot Number: A822215 Product/REF/UDI: PED2-325-10 PIPELINE FLEX SHIELD PED2-325-10 00847536002203 Lot Numbers: A817764 A827602 A847556 Product/REF/UDI: PED2-325-14 PIPELINE FLEX SHIELD PED2-325-14 00847536002227 Lot Numbers: A832011 A832016 Product/REF/UDI: PED2-325-16 PIPELINE FLEX SHIELD PED2-325-16 00847536002234 Lot Numbers: A833044 A833700 A834393 Product/REF/UDI: PED2-325-18 PIPELINE FLEX SHIELD PED2-325-18 00847536002241 Lot Numbers: A830768 A832012 A833701 Product/REF/UDI: PED2-325-20 PIPELINE FLEX SHIELD PED2-325-20 00847536002258 Lot Numbers: A817764 A821515 A821517 A830770 A833702 Product/REF/UDI: PED2-325-25 PIPELINE FLEX SHIELD PED2-325-25 00847536002715 Lot Number: A843367 Product/REF/UDI: PED2-325-30 PIPELINE FLEX SHIELD PED2-325-30 00847536002722 Lot Numbers: A829036 A837012 Product/REF/UDI: PED2-325-35 PIPELINE FLEX SHIELD PED2-325-35 00847536002739 Lot Numbers: A812734 A818460 A822627 Product/REF/UDI: PED2-350-12 PIPELINE FLEX SHIELD PED2-350-12 00847536002272 Lot Number: A819136 Product/REF/UDI: PED2-350-14 PIPELINE FLEX SHIELD PED2-350-14 00847536002289 Lot Numbers: A816345 A816346 A817765 A830771 A830772 A847557 A847558 Product/REF/UDI: PED2-350-16 PIPELINE FLEX SHIELD PED2-350-16 00847536002296 Lot Numbers: A821519 A826276 A827603 A833703 A833704 A838752 A838754 A847559 A852253 A861606 Product/REF/UDI: PED2-350-18 PIPELINE FLEX SHIELD PED2-350-18 00847536002302 Lot Numbers: A811477 A819168 A821521 A833706 A834396 A849722 A864469 A864470 A900741 A900742 A902096 A902097 A906054 Product/REF/UDI: PED2-350-20 PIPELINE FLEX SHIELD PED2-350-20 00847536002319 Lot Numbers: A815075 A816346 A819169 A822208 A838755 A855392 A870618 A871636 A898546 A900744 Product/REF/UDI: PED2-350-25 PIPELINE FLEX SHIELD PED2-350-25 00847536002746 Lot Numbers: A822630 A830777 A837014 A843368 A848680 A861757 A917150 Product/REF/UDI: PED2-350-30 PIPELINE FLEX SHIELD PED2-350-30 00847536002753 Lot Numbers: A813318 A817116 A818461 A826924 Product/REF/UDI: PED2-350-35 PIPELINE FLEX SHIELD PED2-350-35 00847536002760 Lot Numbers: A817117 A822664 A829037 A838762 A848680 A848681 A861758 Product/REF/UDI: PED2-375-10 PIPELINE FLEX SHIELD PED2-375-10 00847536002326 Lot Numbers: A855393 A859750 A871637 A873195 A903562 Product/REF/UDI: PED2-375-12 PIPELINE FLEX SHIELD PED2-375-12 00847536002333 Lot Numbers: A866016 A887303 Product/REF/UDI: PED2-375-14 PIPELINE FLEX SHIELD PED2-375-14 00847536002340 Lot Numbers: A836551 A838756 A861607 Product/REF/UDI: PED2-375-16 PIPELINE FLEX SHIELD PED2-375-16 00847536002357 Lot Numbers: A817766 A827605 A838757 A838758 A861608 A914211 Product/REF/UDI: PED2-375-18 PIPELINE FLEX SHIELD PED2-375-18 00847536002364 Lot Numbers: A812726 A819170 A822209 A834397 A834398 A835004 A849723 A849724 A849725 A871637 A884594 A889028 A890630 A894603 Product/REF/UDI: PED2-375-20 PIPELINE FLEX SHIELD PED2-375-20 00847536002371 Lot Numbers: A835005 A849731 A866017 A881420 A884598 A894604 Product/REF/UDI: PED2-375-25 PIPELINE FLEX SHIELD PED2-375-25 00847536002777 Lot Numbers: A822666 A822667 A832013 A843371 A867847 A869092 A882136 A885864 A887303 Product/REF/UDI: PED2-375-30 PIPELINE FLEX SHIELD PED2-375-30 00847536002784 Lot Numbers: A822668 A837015 A848681 A849905 A867210 Product/REF/UDI: PED2-375-35 PIPELINE FLEX SHIELD PED2-375-35 00847536002791 Lot Numbers: A813318 A818462 A822669 A862921 A870625 Product/REF/UDI: PED2-400-10 PIPELINE FLEX SHIELD PED2-400-10 00847536002388 Lot Number: A882122 Product/REF/UDI: PED2-400-12 PIPELINE FLEX SHIELD PED2-400-12 00847536002395 Lot Numbers: A810946 A852254 A856756 A856757 A859751 A871639 A904258 A904873 A916296 Product/REF/UDI: PED2-400-14 PIPELINE FLEX SHIELD PED2-400-14 00847536002401 Lot Numbers: A856757 A859752 A870618 A871640 Product/REF/UDI: PED2-400-16 PIPELINE FLEX SHIELD PED2-400-16 00847536002418 Lot Numbers: A812727 A812728 A822210 A822210 A830774 A836552 A847560 A849731 A849731 A861609 A861756 A864472 A864474 A865236 A865239 A871933 A882134 A903563 A904237 A904239 A904875 A904876 A916297 A916298 A916299 Product/REF/UDI: PED2-400-18 PIPELINE FLEX SHIELD PED2-400-18 00847536002425 Lot Numbers: A811477 A812729 A812730 A812731 A815076 A827606 A833045 A833046 A833707 A833709 A833710 A836553 A836554 A847561 A847562 A847563 A847564 A847565 A847635 A849732 A849733 A849891 A852255 A864475 A864476 A865240 A865241 A882135 Product/REF/UDI: PED2-400-20 PIPELINE FLEX SHIELD PED2-400-20 00847536002432 Lot Numbers: A811477 A815077 A815078 A815078 A815079 A815080 A815080 A827607 A833105 A833107 A836555 A836555 A847636 A847637 A849892 A849893 A849895 A852256 A864477 A864480 A864482 A865242 A866003 A903567 A916300 A917147 A917148 A918062 A918063 A918069 Product/REF/UDI: PED2-400-25 PIPELINE FLEX SHIELD PED2-400-25 00847536002807 Lot Numbers: A829039 A833712 A843371 A848720 A848722 A858335 A858337 A861758 A871935 A873200 A903566 A904232 A904241 A904906 Product/REF/UDI: PED2-400-30 PIPELINE FLEX SHIELD PED2-400-30 00847536002814 Lot Numbers: A822670 A822671 A830778 A833115 A837018 A843372 A858340 A871936 Product/REF/UDI: PED2-400-35 PIPELINE FLEX SHIELD PED2-400-35 00847536002821 Lot Numbers: A826925 A829042 A835012 A837019 A843372 A843374 A849906 Product/REF/UDI: PED2-425-10 PIPELINE FLEX SHIELD PED2-425-10 00847536002449 Lot Numbers: A811477 A816346 Product/REF/UDI: PED2-425-12 PIPELINE FLEX SHIELD PED2-425-12 00847536002456 Lot Numbers: A811477 A816347 Product/REF/UDI: PED2-425-14 PIPELINE FLEX SHIELD PED2-425-14 00847536002463 Lot Numbers: A838759 A871955 Product/REF/UDI: PED2-425-16 PIPELINE FLEX SHIELD PED2-425-16 00847536002470 Lot Numbers: A811477 A816348 A826462 A830774 A842691 A842691 A842692 A848260 A902098 A902098 Product/REF/UDI: PED2-425-18 PIPELINE FLEX SHIELD PED2-425-18 00847536002487 A816349 A817106 A826463 A827608 A869091 A898549 A900745 Product/REF/UDI: PED2-425-20 PIPELINE FLEX SHIELD PED2-425-20 00847536002494 Lot Numbers: A815080 A817107 A817108 A826464 A827609 A828614 A848261 A898549 A898551 Product/REF/UDI: PED2-425-25 PIPELINE FLEX SHIELD PED2-425-25 00847536002838 Lot Numbers: A813319 A815694 A839454 A839455 A843374 A843374 A898557 A898558 Product/REF/UDI: PED2-425-30 PIPELINE FLEX SHIELD PED2-425-30 00847536002845 Lot Numbers: A822673 A822938 A822939 A822941 A839456 A843374 A918068 Product/REF/UDI: PED2-425-35 PIPELINE FLEX SHIELD PED2-425-35 00847536002852 Lot Numbers: A822942 A839459 A839463 A839466 Product/REF/UDI: PED2-450-10 PIPELINE FLEX SHIELD PED2-450-10 00847536002500 Lot Numbers: A817767 A918065 Product/REF/UDI: PED2-450-12 PIPELINE FLEX SHIELD PED2-450-12 00847536002517 Lot Numbers: A849896 A859753 A862918 A871933 A873197 A904253 Product/REF/UDI: PED2-450-14 PIPELINE FLEX SHIELD PED2-450-14 00847536002524 Lot Numbers: A862919 A866018 A866019 A870621 Product/REF/UDI: PED2-450-16 PIPELINE FLEX SHIELD PED2-450-16 00847536002531 Lot Numbers: A815080 A822210 A826464 A828615 A842693 A842694 A848262 A849897 A852720 A852721 A854046 A855394 A858331 A868555 A868564 A869091 A894605 Product/REF/UDI: PED2-450-18 PIPELINE FLEX SHIELD PED2-450-18 00847536002548 Lot Numbers: A811479 A815080 A822211 A826465 A828616 A833109 A842695 A848263 A854048 A858332 A858334 A859754 A859755 A867846 A868565 A871934 A871935 A894606 A918066 Product/REF/UDI: PED2-450-20 PIPELINE FLEX SHIELD PED2-450-20 00847536002555 Lot Numbers: A811480 A815080 A815080 A815080 A815080 A815691 A817109 A817110 A817769 A818290 A833111 A866021 A866023 A866025 A868566 A869091 A890631 A897350 A897354 A897358 A903543 Product/REF/UDI: PED2-450-25 PIPELINE FLEX SHIELD PED2-450-25 00847536002869 Lot Numbers: A815695 A815696 A826926 A826926 A829043 A830779 A839468 A843374 A843375 A852256 A854050 A858341 A858342 A861759 A894607 A896157 A918070 Product/REF/UDI: PED2-450-30 PIPELINE FLEX SHIELD PED2-450-30 00847536002876 Lot Numbers: A822943 A826926 A839471 A843376 A843376 A852257 A854051 A854052 A856680 A858343 A864484 A866004 A899364 Product/REF/UDI: PED2-450-35 PIPELINE FLEX SHIELD PED2-450-35 00847536002883 Lot Numbers: A839474 A839878 A854055 A854056 A854061 A869085 Product/REF/UDI: PED2-475-12 PIPELINE FLEX SHIELD PED2-475-12 00847536002579 Lot Numbers: A826465 A885863 Product/REF/UDI: PED2-475-14 PIPELINE FLEX SHIELD PED2-475-14 00847536002586 Lot Numbers: A822212 A854049 A855395 A873198 A903566 Product/REF/UDI: PED2-475-16 PIPELINE FLEX SHIELD PED2-475-16 00847536002593 Lot Numbers: A815692 A828617 A835008 A842696 A848660 A848661 A889029 A898552 A904230 Product/REF/UDI: PED2-475-18 PIPELINE FLEX SHIELD PED2-475-18 00847536002609 Lot Numbers: A812732 A819171 A833711 A835009 A837011 A838760 A849898 A849898 A849904 A878855 A878856 A899361 Product/REF/UDI: PED2-475-20 PIPELINE FLEX SHIELD PED2-475-20 00847536002616 Lot Numbers: A812733 A817110 A817111 A817112 A826466 A826467 A826919 A826920 A828618 A866412 A867208 A869083 A885863 A894159 A898555 A900746 A900747 A900749 A902100 Product/REF/UDI: PED2-475-25 PIPELINE FLEX SHIELD PED2-475-25 00847536002890 Lot Numbers: A813320 A822944 A822945 A830780 A833117 A835014 A837020 A843378 A848723 A848724 A900750 Product/REF/UDI: PED2-475-30 PIPELINE FLEX SHIELD PED2-475-30 00847536002906 Lot Numbers: A815697 A817117 A819203 A826926 A833119 A835015 A835018 A848724 A852543 A869085 A900752 A902101 Product/REF/UDI: PED2-475-35 PIPELINE EMB DEVICE PED2-475-35 00847536002913 Lot Numbers: A833713 A833714 A833715 A835019 A848724 A849911 A850777 A879717 A879718 A879719 Product/REF/UDI: PED2-500-12 PIPELINE FLEX SHIELD PED2-500-12 00847536002630 Lot Numbers: A812095 A818300 A819172 Product/REF/UDI: PED2-500-14 PIPELINE FLEX SHIELD PED2-500-14 00847536002647 Lot Numbers: A812733 A818301 A822213 Product/REF/UDI: PED2-500-16 PIPELINE FLEX SHIELD PED2-500-16 00847536002654 Lot Numbers: A822213 A833113 A867209 A868567 Product/REF/UDI: PED2-500-18 PIPELINE FLEX SHIELD PED2-500-18 00847536002661 Lot Numbers: A822215 A829030 A830775 A838761 A848676 A848677 A897361 A899362 Product/REF/UDI: PED2-500-20 PIPELINE FLEX SHIELD PED2-500-20 00847536002678 Lot Numbers: A815693 A817113 A817115 A826921 A826921 A826922 A829031 A830776 A833114 A835010 A862920 A889033 A894607 A896155 A896155 A897363 A897365 Product/REF/UDI: PED2-500-25 PIPELINE FLEX SHIELD PED2-500-25 00847536002920 Lot Numbers: A822946 A826927 A830781 A835020 A837021 A837022 A897367 A897369 Product/REF/UDI: PED2-500-35 PIPELINE EMB DEVICE PED2-500-35 00847536002944 Lot Numbers: A822947 A839879 A873200 A899368 A903564 B005844

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88447
Status: Active
Manufacturer: Micro Therapeutics Inc,
Manufactured In: United States
Units Affected: 2 products (16,169 total devices for all model/products)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.