Boston Scientific ICEfx Cryoablation System Recall: Loose Desiccant Tube Risk
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.
Lower-risk recall
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/51596-boston-scientific-icefx-cryoablation-system-recall-loose-desiccant-tube-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51596-boston-scientific-icefx-cryoablation-system-recall-loose-desiccant-tube-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2550-2025
Cite this page
“Boston Scientific ICEfx Cryoablation System Recall: Loose Desiccant Tube Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51596-boston-scientific-icefx-cryoablation-system-recall-loose-desiccant-tube-risk. Based on FDA recall #Z-2550-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2550-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Medical professionals using the ICEfx Cryoablation System for procedures are most at risk. Patients receiving treatments with these units may also be affected.
How to tell if you have this one
Check for Material Numbers (UPN) FPRCH8000, FPRCH8000-02, or H749396118000. Also look for specific serial numbers listed in the recall notice.
- Brand
Boston Scientific- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2550-2025 | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000; FPRCH8000 UDI-DI: 00859019006370, Serial Numbers: ICP0305, ICP0369, ICP0338; FPRCH8000-02 UDI-DI: 00859019006417, Serial Numbers: 86643865, 108415728, 88589050, 108470986, 89392275, 108612524, 107799735, ICP0299, 107887794, 3779, 108254011, IF0096 108312221, 104733618; H749396118000 UDI-DI: 00191506014995, Serial Numbers: 106066356, 107851990 | 18 units |
| Z-2551-2025 | Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000; Batch: 108159110 | 1 unit |
What to do — step by step
Check Product Details
Review the Material Numbers (UPN) and serial numbers listed in the recall notice to confirm if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 30 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2550-2025 (August 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2550-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.