FDA-Device2025-09-17Class II
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Hazard
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Sold states
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
Affected count
18 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2550-2025More Boston Scientific Corporation recalls
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- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific TheraSphere 360 Y-90 software anomaly may cause incorrect dose calculations
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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