Class 2 Device Recall ICEfx Cryoablation System

• Date Initiated by Firm: August 18, 2025
• Date Posted: September 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2550-2025
• Recall Event ID: 97466
• 510(K)Number: K234002
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
• 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
• FEI Number: 3002095335
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: 763-494-1700
• Manufacturer Reason for Recall: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
• FDA Determined Cause: Process control
• Action: An Urgent Medical Device Correction dated 8/18/25 was sent to customers. Customers should cease use of the systems listed in Table 1 and segregate them until a Boston Scientific representative has corrected this issue. A Boston Scientific Field Service Engineer will contact your facility to schedule the correction of your system. For patients in whom an impacted device has already been used, there are no specific recommendations beyond the local standard post-procedure care. If you require additional assistance or more information regarding this communication, please contact your local Boston Scientific representative. The Acknowledgement Form enclosed with this product correction must be completed and returned even if you do not have any affected units. An Urgent Medical Device Removal notification letter dated 8/18/25 was sent to a customer regarding the PM Kit ICEFX. Instructions: 1. Further distribution or use of any devices (Table 1) affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page three. 5. Return affected devices. If you require additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.
• Quantity in Commerce: 18 units
• Distribution: Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEH