Boston Scientific Corporation Recall 95514
Description: Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Boston Scientific Corporation Recall 95514 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0300-2025 |
Event ID | 95514 |
Event Description | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060 |
Product Type | Devices |
Distribution | Worldwide |
Quantity | 960 units |
Recall Reason | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
Device Classification | 20241120 |
Device Code Info | GTIN 08714729992622 |
Center Classification Date | 20241112 |
Recall Initiation Date | 20241010 |
Recalling Firm | Boston Scientific Corporation |
Initial Notification | Letter |
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