Boston Scientific Corporation Recall: Boston Scientific POLARx BALLOON CATHETER LT 28MM OU
Boston Scientific Corporation Recall: Boston Scientific POLARx BALLOON CATHETER LT 28MM OU is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100; Reason for recall: Bos
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Product | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100 |
| Reason for recall | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Worldwide |
| Recall initiated | 20241010 |
| Recall number | Z-0298-2025 |
| Category | device |
| State | MN |
| Country | United States |
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