Boston Scientific Corporation Recall: AXIOS Stent and Delivery System 10mmx10mm UPN: M0055
Boston Scientific Corporation Recall: AXIOS Stent and Delivery System 10mmx10mm UPN: M0055 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740; Reason for recall: Reported Outer sheath distal b
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Product | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Nationwide including Puerto Rico Foreign: To be provided |
| Recall initiated | 20241220 |
| Recall number | Z-1030-2025 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
Try RecallGuard →