Z-2550-2025Class II

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

Name: Z-2550-2025 ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000...
Creator: Boston Scientific Corporation
Published: 2025-08-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-08-18 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 on 2025-08-18. FDA classified it as Class II and gives the reason as "Certain desiccant tube subassemblies were built with end caps that were not correctly tightened". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2550-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-18
Posted: 2025-09-11
Recalling firm: Boston Scientific Corporation
Product: ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Root cause tag: manufacturing process
FDA root 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.)
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2550-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2550-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11
Z-2551-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11

Product code GEH

K234002Class IIICEfx Cryoablation System (FPRCH8000-02)Boston Scientific / cleared 2024-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)