Class II

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

Boston Scientific Corporation · August 18, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

18 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2550-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.