Medtronic NanoCross Elite PTA catheter recall
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X…
Why was Medtronic NanoCross Elite PTA catheter recalled?
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X…
- Recalling firm
- ev3 Inc
- 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.
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)