BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
FDA device recall Z-1754-2025 · posted 2025-05-13 · Terminated
Recall details
- Recalling firm
- Numed Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- NVM
- Quantity affected
- 4 units
- Distribution
- US distribution to Pennsylvania.
- Date initiated
- 2025-04-21
- Date posted
- 2025-05-13
- Date terminated
- 2025-12-17
- Location
- Hopkinton, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIB PTA BALLOON CATHETER (K050857) | NuMED, Inc. | 2005-07-28 |