Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS — Class I medical device recall Z-0298-2025
Ongoing recall by Boston Scientific Corporation, reported 2024-11-20. Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Cat
| Recall number | Z-0298-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2024-10-10 |
| Classified | 2024-11-12 |
| Reported by FDA | 2024-11-20 |
| Quantity | 20,290 units |
| UPC / GTIN / UDI-DI | 08714729992660 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0298-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.