Recalls / —

—#215650

Product

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

FDA product code

GEH — Unit, Cryosurgical, Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K234002

Affected lot / code info

Batch: 108159110

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern

Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)

Timeline

Recall initiated

2025-08-18

Posted by FDA

2025-09-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #215650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.