Recall Z-0303-2025— 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 SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0. 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 SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
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.