Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Boston Scientific POLARx FIT BALLOON CATHETER ST US Recalled by Boston Scientific Corporation Due to Boston Scientific is updating the instructions for use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Quantity: 960 units
Why Was This Recalled?
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Where Was This Sold?
Worldwide
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report