Recall Z-2533-2025 ยท PTM Syringe, Balloon Inflation, Exempt
Boston Scientific Corporation
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
| Date | Sep 5, 2025 (initiated Aug 5, 2025) |
| Status | Open, Classified |
| Reason | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued an Urgent Medical Device Removal notice to it consignees on 8/5/2025 via letter delivered using a traceable means. The notice explained the issue. potential adverse health consequences associated with use in each device and requested the following instructions be followed: 1. Further distribution or use of any remaining devices affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately |
| Quantity | 39739 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.