Recall Z-0904-2025 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
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 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
| Date | Jan 15, 2025 (initiated Dec 10, 2024) |
| Status | Open, Classified |
| Reason | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. |
| Root cause | Process change control |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/10/2024 via mail courier. The notice explained the issue, potential harms, and requested the following actions be taken: "" Immediately locate and quarantine all affected and unused NanoCross devices as listed in the provided scope. " Return all unused affected products in your inventory to Medtronic. Contact Medtronic Vascular Customer Service at 800-716-6700 to initiate a product return. Your local Medtronic Representative can assist you with the initiation of the return. " Complete and return the Customer |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER Ev3, Inc., Jul 18, 2014 |