Boston Scientific Corporation Recall 96049
Description: AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Boston Scientific Corporation Recall 96049 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1030-2025 |
| Event ID | 96049 |
| Event Description | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 |
| Product Type | Devices |
| Distribution | Nationwide including Puerto Rico Foreign: To be provided |
| Quantity | 12 units |
| Recall Reason | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. |
| Device Classification | 20250205 |
| Device Code Info | GTIN: 08714729904625 Lot Numbers: 34477280 |
| Center Classification Date | 20250130 |
| Recall Initiation Date | 20241220 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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