Medtronic Vascular: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.; Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasc

Agency Publication Date: November 15, 2013

Affected Products

Product: Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Med

G13A00104 G13A00105 G13A00106 G13A00107 G13A00108 G13A00109 G13A00110 G13A00112 G13A00113 G13A00114 G13A00692 G13A00713 G13A00734 G13A00788 G13A00803 G13A00804 G13A00809 G13A00810 G13A00811 G13A00874 G13A00971 G13A00972 G13A00973 G13A00974 G13A00975 G13A00976 G13A00977 G13A00978 G13A00979 G13A00980 G13A00981 G13A00982 G13A01016 G13A01017 G13A01330 G13A01400 G13A01401 G13A01409 G13A01410 G13A01411 G13A01446 G13A01449 G13A01452 G13A01569 G13A01584 G13A01600 G13A01604 G13A01605 G13A01606 G13A01607 G13A01608 G13A01609 GV827 GV829 GV830 GV831 GV832 GV835 GV836 GV837 GV838 GV839 GV840 GV844 GV845 GW405 GW406 GW407 GW508 GW509 GW510 GW675 GW687 GW688 GW706 GW710 GW745 GW746 GV824

Product: Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are

G13A00123 G13A00870 G13A00910 G13A00911 G13A00920 G13A00921 G13A00931 G13A00939 G13A00940 G13A01270 G13A01271 G13A01352 G13A01354 G13A01355 G13A01477 G13A01478 G13A01622 G13A01623 G13A01624 G13A01640 G13A01641 G13A01651 GV875 GV876 GW594 GW683 GW695

Product: THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventi

G13A00117 G13A00735 G13A00792 G13A00794 G13A01324 GV259 GV261 GV276 GV287 GV847 GV848 GV849 GV851 GV852 GW690 GW758 GU141 GU959

Product: ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitut

G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 Additional Lots Identified: GV143 GV926 GV927 G13A00133 G13A00134 G13A01167 G13A01912 G13A00136 G13A00137 G13A01938

Product: ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694

Product: COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional d

G13A00805 G13A00814 G13A00815 G13A01447 G13A01450 GW547

Product: THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.

G13A00116 G13A00936 GV260 GV846

Product: ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one di

G13A00118 G13A00715 G13A00716 G13A00843 G13A00937 G13A01601 G13A01620 G13A01621 G13A01638 G13A01639 G13A01650 GV854 GW761

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66567

Status: Resolved

Manufacturer: Medtronic Vascular

Manufactured In: United States

Units Affected: 7 products (10,230; 1,239; 58; 1674; 20; 1205; 5)

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Sources: FDA iRES · Raw API Response

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