Medtronic NanoCross Elite PTA catheter — Class II medical device recall Z-0904-2025
Ongoing recall by ev3 Inc, reported 2025-01-22, distributed nationwide. There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the
| Recall number | Z-0904-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ev3 Inc, Plymouth, MN, United States |
| Recall initiated | 2024-12-10 |
| Classified | 2025-01-14 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CY, DE, EE, ES, IT, JO, JP |
| Quantity | 5,189 units |
| UPC / GTIN / UDI-DI | 00763000758035, 00763000758042, 00763000758059, 00763000758066, 00763000758080, 00763000758097, 00763000758103, 00763000758141, 00763000758165, 00763000758172, 00763000758189, 00763000758219, 00763000758226, 00763000758240, 00763000758264, 00763000758288, 00763000758301, 00763000758325, 00763000758349, 04987742337815, 04987742337891, 04987742337907 |
| Serial numbers | B726348, B727462, B730835, B730934, B731160, B734091, B734116, B734241, B736196, B736200, B737344, B738596, B740725, B740732, B748628, B748644, B748659, B748690, B749440, B749498, B749504, B749509, B750054, B750081, B750625 and 107 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0904-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.