Recall Z-2550-2025— Boston Scientific Corporation

Name: FDA recall Z-2550-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-18

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2025-08-18. It names one FDA 510(k) clearance: K234002. Product: ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000. Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-08-18
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K234002 — ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific·cleared 2024-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.