FDA-Device2024-11-20Class I
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Hazard
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Sold states
Worldwide
Affected count
2751 units
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2025More Boston Scientific Corporation recalls
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