FDA Device recall Z-0301-2025
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
- FDA Device
- Class I
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class I recall of Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110 by Boston Scientific, citing boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0301-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-10 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Reason
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Identifiers
| code_info | GTIN00191506016456 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0301-2025%22
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