Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

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.

• FDA enforcement recordOfficial FDA database entry for Z-2551-2025
• FDA 510(k) clearance · K234002The device's official FDA premarket clearance record
• FDA device classification · GEHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.