Recall Z-2551-2025 ยท GEH Unit, Cryosurgical, Accessories
Boston Scientific Corporation
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
| Date | Sep 11, 2025 (initiated Aug 18, 2025) |
| Status | Open, Classified |
| Reason | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 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 Bost |
| Quantity | 1 unit |
| Distribution | Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) Boston Scientific, Mar 13, 2024 |