Recall Z-0297-2025— Boston Scientific Corporation
Class I · Ongoing
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2024-10-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.. Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-10-10
- Firm location
- Saint Paul, MN, United States
Product description
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.