FDA-Device2024-11-20Class I
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Boston Scientific Corporation
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
4422 units
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0297-2025Don't want to check this manually?
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