Boston Scientific recalls ICEfx Cryoablation System units with specific material numbers and serials due to desiccant tube subassemblies that may not be correctly tightened, potentially causing leaks.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Boston Scientific is recalling certain ICEfx Cryoablation Systems that have desiccant tube subassemblies with end caps not properly tightened. This could lead to leaks, which might cause equipment damage or affect medical procedures.
The desiccant tube subassemblies have end caps that were not correctly tightened during manufacturing. This could cause leaks in the system, potentially leading to equipment damage or affecting the medical procedure.
Medical professionals using the ICEfx Cryoablation System for procedures are most at risk. Patients receiving treatments with these units may also be affected.
Check for Material Numbers (UPN) FPRCH8000, FPRCH8000-02, or H749396118000. Also look for specific serial numbers listed in the recall notice.
Review the Material Numbers (UPN) and serial numbers listed in the recall notice to confirm if your unit is affected.
The recall includes ICEfx Cryoablation Systems with Material Numbers (UPN) FPRCH8000, FPRCH8000-02, and H749396118000.
Check for the Material Numbers (UPN) FPRCH8000, FPRCH8000-02, or H749396118000 and the specific serial numbers listed in the recall notice.
The recall notice does not specify a remedy, so you should check with Boston Scientific directly for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2550-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2550-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
