Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5M...
FDA Recall #Z-0904-2025 — Class II — December 10, 2024
Product Description
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 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter
Reason for Recall
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Recalling Firm
ev3 Inc — Plymouth, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5189 units
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.
Code Information
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, B754889, B754921, B754938, B754944, B762313, B762346, B762623, B762814, B762967, B781392, B791857, B792372, B798527; 13) AB14W060040090, UDI/DI 00763000758219, Serial Numbers: B730934, B795892; 14) AB14W060040150, UDI/DI 00763000758226, Serial Numbers: B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013; 15) AB14W060060150, UDI/DI 00763000758240, Serial Numbers: B762430, B762853, B791832; 16) AB14W060080150, UDI/DI 00763000758264, Serial Numbers: B755686, B761181, B762366, B762433, B762921, B793869; 17) AB14W060100150, UDI/DI 00763000758288, Serial Numbers: B748690, B759617, B762803, B769628, B781383, B792612; 18) AB14W060120150, UDI/DI 00763000758301, Serial Numbers: B762187, B766265, B789926; 19) AB14W060150150, UDI/DI 00763000758325, Serial Numbers: B730835, B734241, B757655, B758869, B761533, B776389, B781300, B791875; 20) AB14W060200150, UDI/DI 00763000758349, Serial Numbers: B726348, B736196, B749504, B750650, B754900, B761765, B762193, B769612, B769616, B769622, B769634, B781989, B792379.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.