ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN)...
FDA Recall #Z-2550-2025 — Class II — August 18, 2025
Product Description
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Reason for Recall
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Recalling Firm
Boston Scientific Corporation — Maple Grove, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
18 units
Distribution
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
Code Information
FPRCH8000 UDI-DI: 00859019006370, Serial Numbers: ICP0305, ICP0369, ICP0338; FPRCH8000-02 UDI-DI: 00859019006417, Serial Numbers: 86643865, 108415728, 88589050, 108470986, 89392275, 108612524, 107799735, ICP0299, 107887794, 3779, 108254011, IF0096 108312221, 104733618; H749396118000 UDI-DI: 00191506014995, Serial Numbers: 106066356, 107851990
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated