CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
ICEfx Cryoablation System, portable helium-free desktop recalled
Boston Scientific is recalling ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material, distributed nationwide in the US. The recall was initiated on 18 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2550-2025
- FDA event ID
- 97466
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2025
- FDA classified
- 11 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Aug 2025 | Recall initiated by company | |
| 11 Sep 2025 | Classified by FDA | +24 days |
| 17 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Product as listed by the FDA
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Where it was distributed
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
Questions about this recall
Why was it recalled?
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97466| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Preventive Maintenance (PM) Kit Icefx, Material Number recalled | Boston Scientific | Other | Nationwide |
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