Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

Recalled November 20, 2024 · FDA recall Z-0298-2025 · Boston Scientific

Hazard

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. · FDA Class I

Units

20290 units

Sold at

Worldwide

Description

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Product

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →