Recall Z-1754-2025 ยท NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Numed Inc
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
| Date | May 13, 2025 (initiated Apr 21, 2025) |
| Status | Terminated |
| Reason | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon. |
| Root cause | Mixed-up of materials/components |
| Action | NuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at nlaflesh@numedusa.com. |
| Quantity | 4 units |
| Distribution | US distribution to Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050857 | BIB PTA BALLOON CATHETER NuMED, Inc., Jul 28, 2005 |