ev3 Inc: Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 9

Hazard

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

Details from the source

Reason for recall: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. Distribution: Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen. Quantity: 5189 units Lot/code info: 1) AB14W050020090, UDI/DI 00763000758035, Serial Numbers: B738596, B749440, B764968; 2) AB14W050020150, UDI/DI 00763000758042, Serial Numbers: B761521, B781264, B794814; 3) AB14W050040090, UDI/DI 00763000758059, Serial Numbers: B740725, B748628; 3) AB14W050040090, UDI/DI 04987742337891, Serial Numbers: B740725; 4) AB14W050040150, UDI/DI 00763000758066, Serial Numbers: B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995; 4) AB14W050040150, UDI/DI 04987742337907, Serial Numbers: B755679; 5) AB14W050060150, UDI/DI 00763000758080, Serial Numbers: B755683, B761779, B762646, B792990; 6) AB14W050080090, UDI/DI 00763000758097, Serial Numbers: B797860; 7) AB14W050080150, UDI/DI 00763000758103, Serial Numbers: B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874; 8) AB14W050100150, UDI/DI none, Serial Numbers: B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118; 9) AB14W050120150, UDI/DI 00763000758141, Serial Numbers: B731160, B761782, B762036, B768737, B793229; 10) AB14W050150150, UDI/DI 00763000758165, Serial Numbers: B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222; 11) AB14W050200090, UDI/DI 00763000758172, Serial Numbers: B760301, B789934; 11) AB14W050200090, UDI/DI 04987742337815, Serial Numbers: B760301; 12) AB14W050200150, UDI/DI 00763000758189, Serial Numbers: B734116, B740732, B749498, B749509, B754865, B754876, B75488

UPC codes

00763000758035, 00763000758042, 00763000758059, 04987742337891, 00763000758066, 04987742337907, 00763000758080, 00763000758097, 00763000758103, 00763000758141, 00763000758165, 00763000758172, 04987742337815, 00763000758189, 00763000758219, 00763000758226, 00763000758240, 00763000758264, 00763000758288, 00763000758301, 00763000758325, 00763000758349

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.