Maquet Cardiovascular, LLC: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Agency Publication Date: May 4, 2020

Affected Products

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1070624412 1072306151 1072300424 1123884494 1131457231 1131669419 1133302679 1151507540 1151511687 1152707813 1152559041 1152750757 1070621236 1070629009 1074513986 1074512017 1123911970 1131472773 1131605144 1152580776 1153707701

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1161660408 1161660759 1161660154 1168595437 1168596216 1168588836 1168591619 1168601507 1168586068 1174957059 1174946035

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1133295245 1143826089

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1130028529 1138737382 1151582817 1151580283 1153694149 1158765278 1165139009 1165161757 1165201073 1165174827 1165129349 1165209939 1165131353 1165124986 1180826106 1138872368 1153712022 1157288202 1158765044 1165159382

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1136624666 1141287370 1145851672 1148863744 1149775174 1141180252 1148845748 1148847286 1148860100 1149750672 1157249639 1157251155 1157376991

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1136650764 1136649656 1138918524 1139377657 1143579436 1143599946 1147678079 1152754107 1158302730 1159727382 1159721538 1163859207 1166883762 1172730370 1177896586 1138937162 1141871928 1148785668 1152764001 1158785925 1159740547 1163841540 1168007426 1177892046

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1131533749 1131512226 1137644576 1143574839 1143575130 1148758791 1148780115 1148765763 1148821303 1148781616 1148788961 1148782980 1162315753 1165124869 1192273190 1135377032 1136549649 1137644693 1148748780 1162373559

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1174771828 1174771106 1174769941

Product: Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1175589583 1175603872 1175612382 1179652954 1179653616

Product: Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease

Serial Numbers: 1175590223 1175624927 1179649703 1183011925 1183008537 1183011066 1191609117 1191599092 1183020201 1183073432 1183039720

Product: Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1176626841 1176624815 1176637748 1176630871

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1126809369 1128053768 1183546961 1158773400

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1173942817 1173968078 1173846374

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1185764630

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1124104830 1165164445

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1144930522 1126647022 1158303372

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1150580161 1169537519 1150585480 1151593236 1152755120 1169495064 1172726691

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1120090850 1120109758 1120080956 1120074392 1120099148 1137597566 1137603753 1183458035

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1069833603 1069800979 1069830915 1069822813 1069826494 1073232852 1073244538 1073248356 1073247694 1073238111 1073244655 1073245805 1074078868 1074096981 1073245180 1075816095 1075833820 1075817616 1075822171 1121372880 1121440106 1121438219 1121372041 1121396486 1121390993 1121413834 1121410287 1123883969 1123881709 1123882605 1126691350 1131379994 1150412103 1150432593 1150316987 1150489896 1150511448 1150483701 1162227315 1162227920 1162231345 1177013851 1176957069 1177022361 1177037106 1177062054 1180553781 1180752802 1184425670 1073247948 1073255445 1075827022 1080534907 1120128533 1120067440 1121368128 1121428442 1121415860 1123880071 1150432730 1150485356 1150485473 1180546087 1184503258 1187865172

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1070172386 1070172035 1070165805 1070170614 1069855417 1070722490 1070716317 1070692463 1070716668 1073219687 1073220795 1073223015 1074236324 1073239612 1074517570 1079999309 1079997985 1080000259 1080547235 1080509568 1080566478 1080564686 1108346226 1111646683 1111648592 1111705379 1111680044 1111803731 1111646078 1111719462 1115868785 1117833189 1117882017 1117871578 1117912903 1117878104 1117848422 1117847877 1118870707 1118858809 1118864514 1146813425 1146795181 1146785287 1146815568 1150324250 1150260235 1150306859 1150311668 1150308046 1150468978 1150337808 1150339112 1150343747 1170653063 1170656610 1170622485 1170679066 1177871479 1177878356 1177890859 1177920418 1179061656 1179078310 1179110087 1181320446 1185194855 1073228334 1074228944 1074241016 1073226893 1076688092 1079998881 1111672293 1113494240 1146788600 1150471761 1185747042 1185791370

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1069016915 1069016778 1069024392 1069023633 1069020945 1069017069 1069887359 1070175211 1070689212 1070691938 1070692229 1073307657 1073274083 1074239734 1074508943 1076726963 1076724195 1076691012 1080515527 1080502574 1080516052 1080521115 1080517807 1080517202 1080511104 1082496280 1107410936 1107401196 1107412006 1108349382 1108384849 1109527236 1109536351 1109582959 1109545837 1109638521 1109712993 1112019301 1112016613 1112016964 1112016730 1112017860 1112017489 1112018385 1112051221 1112030283 1113457118 1113461382 1113412574 1113446562 1113429579 1115826461 1115864128 1115914431 1115914548 1115827123 1115899734 1115897708 1115825331 1115890109 1115890226 1116687063 1116670058 1116665366 1116796185 1118783633 1118872362 1118683489 1118680938 1118706076 1118855516 1118677296 1118857425 1118863618 1118853607 1118865156 1118868449 1120124949 1120151826 1120162616 1120197246 1120115580 1121427175 1121369492 1121368479 1121432004 1121402790 1121367720 1121381761 1121406257 1121461746 1121476608 1123956748 1124038791 1126619737 1126648874 1126652924 1126635453 1126606550 1139533672 1139548534 1139546508 1139558662 1139544833 1139556753 1139580083 1143639633 1145774258 1145827483 1145775271 1145857887 1146721149 1146735095 1146730264 1146737492 1146826241 1146794051 1146827488 1148863022 1150323725 1150325029 1150370975 1150390392 1150368503 1150338567 1150381414 1150319792 1150511214 1150545319 1150343259 1150599075 1150400300 1150603119 1151562307 1152518823 1152580288 1152720119 1152745089 1152748987 1152536448 1152735683 1152740863 1152618108 1160497045 1160563181 1160479908 1161618086 1161644067 1162218200 1162252517 1163879834 1163823544 1177064705 1177726014 1177810868 1177845264 1177799150 1177805708 1177743114 1177779362 1177757294 1177825964 1177745140 1177845030 1177719159 1177852470 1177816595 1177746524 1177754509 1177736376 1179122144 1179142049 1179115543 1181358135 1181256570 1181240695 1181268490 1183390553 1183404630 1183478311 1183415654 1183468651 1183413979 1187307214 1187389094 1187417095 1187330507 1187300825 1187835978 1187956786 1187944866 1193768558 1193816581 1193808479 1082495033 1112036986 1112023448 1118781236 1120191519 1136545831 1150382427 1152581184 1179154711 1181135879 1187301721 1187924473 1187392619

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1069844373 1069859235 1070838372 1070706306 1070885876 1070696535 1070880206 1070698932 1070693359 1070875260 1070859895 1071599689 1071623404 1071635929 1071640855 1071595383 1072244650 1072221218 1072235164 1073312349 1074236187 1074521366 1075883407 1076662460 1076662089 1076657163 1076657651 1077516221 1077516455 1077512637 1077509366 1077515793 1077506795 1077514292 1077510006 1077509132 1080021177 1080028425 1080022190 1080038065 1080016505 1080020047 1080020906 1080022444 1080034247 1080026145 1107350739 1107370878 1107397055 1107542300 1107356954 1107534803 1111727076 1111767628 1111828116 1111802952 1111831484 1111976640 1111962791 1111974477 1111985521 1111988794 1111989573 1111991831 1111960882 1111934296 1113454547 1113439727 1113459983 1113457606 1113464792 1113410548 1113473439 1115874978 1115872835 1115914782 1115896441 1115917119 1115900231 1115900953 1115936616 1115917841 1115915444 1115918249 1116670546 1116664587 1116654947 1116679332 1116771449 1116675865 1116657147 1117803878 1117890119 1117889596 1123969330 1123996558 1124010762 1123975523 1123968785 1124016489 1124033238 1123954839 1124030667 1123982592 1124038069 1123990226 1124016977 1126833792 1129566390 1129565748 1131391775 1134353909 1134350733 1134353284 1134370267 1139544111 1139533926 1139541540 1139536009 1146817477 1150356075 1151513850 1151507306 1151527816 1151544428 1169424559 1169388690 1171544434 1171540733 1171618089 1171564710 1171541375 1173579328 1173699240 1182769446 1182698342 1182756864 1182709126 1184446354 1184412971 1184445946 1184453326 1184450033 1187301116 1187336000 1187866556 1189130132 1189111006 1190531014 1190781708

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1071592227 1076652332 1076651924 1077530262 1077532425 1077534451 1115874139 1117809371 1117812408 1117796327 1117794535 1117789960 1117809020 1117815935 1117814805 1123951175 1123988085 1124019782 1124040327 1124021181 1124006732 1129589959 1129634943 1129655139 1136595906 1137613764 1139537978 1143684135 1146721032 1146770074 1146753833 1146714548 1146754846 1146767428 1160528085 1160522358 1160540588 1160489919 1185176976 1185742445 1187300337 1187355243 1187336585 1072226283 1115901732 1117786179 1124002055 1123995779 1137600948 1139535952 1143697322 1146723800 1146725221 1160566357

Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Serial Numbers: 1069033761 1069030839 1071600069 1071620833 1071615770 1071620950 1074557517 1074562931 1077531880 1109551893 1109625685 1113411073 1115932310 1160529586 1160492194 1160491552 1160727457 1160529957 1182769563 1182780936 1182789351 1182792017 1183481796 1069032514 1115876907 1115936362 1137588685

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85420

Status: Resolved

Manufacturer: Maquet Cardiovascular, LLC

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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