Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0

Recalled September 17, 2025 · FDA recall Z-2550-2025 · Boston Scientific

Hazard

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. · FDA Class II

Units

18 units

Sold at

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

Description

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Product

ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

Manufacturer(s)

Boston Scientific Corporation

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