Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/
Check against the official notice below — it lists the full affected range.
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
Reason for recall: Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. Distribution: Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Quantity: 262,686 Lot/code info: M001314001 UDI-DI 08714729354826 Batches 74B2500089 74C2600048 74E2500888 74G2500942 74H2500390 74K2400624 74K2500754 74L2400920 M001314011 UDI-DI 08714729354833 Batches 74B2500937 74F2500509 74L2400427 74L2400913 74L2500679 74M2400314 M001314021 UDI-DI 08714729354840 Batches 74A2500370 74C2500582 74E2500889 74E2600070 74G2500421 74H2500875 74K2400982 74K2500755 74L2500841 M001314031 UDI-DI 08714729354857 Batches 74B2501237 74D2600727 74F2500968 74M2400317 M001314041 UDI-DI 08714729354864 Batches 74A2500996 74B2600070 74D2501155 74D2600456 74G2500951 74K2401116 M001314051 UDI-DI 08714729354871 Batches 74A2500586 74A2500997 74B2500090 74B2500711 74B2500940 74B2501238 74B2600079 74B2600310 74B2600390 74B2600412 74B2600573 74C2501047 74C2600348 74C2600430 74C2600531 74D2500124 74D2500424 74D2501156 74D2600455 74D2600857 74D2601116 74E2500982 74E2501194 74F2500511 74F2500599 74F2500768 74G2500422 74G2500759 74G2501153 74G2501349 74H2500392 74H2500659 74H2500665 74H2501042 74J2500318 74J2500552 74K2401330 74K2500164 74K2500756 74K2500917 74L2400720 74L2500033 74L2500680 74M2400072 74M2400304 74M2400318 74M2500245 M001314061 UDI-DI 08714729354888 Batches 74A2500044 74A2500587 74A2600261 74A2600415 74B2500091 74B2500488 74B2600080 74B2600895 74C2500053 74C2500583 74C2600350 74D2500125 74D2500426 74D2600575 74E2500201 74E2500293 74E2500981 74E2501195 74F2500969 74G2500778 74G2501350 74H2501041 74J2500085 74K2400625 74K2500759 74L2400041 74L2400411 74L2400418 74L2401248 74L2401259 74L
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.