ICEfx Cryoablation System recalls: loose desiccant tube end caps
Boston Scientific is recalling certain ICEfx Cryoablation System units worldwide due to desiccant tube end caps that were not correctly tightened during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a structural assembly defect. No reported injuries or illnesses are documented. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling certain ICEfx Cryoablation System units due to a manufacturing defect in the desiccant tube subassemblies. The end caps on affected units were not correctly tightened.
The recalled units were distributed worldwide, including throughout the US and in Canada, France, Germany, and Italy. A total of 18 units with this defect have been identified. The specific affected products are identified by their material numbers (UPN): FPRCH8000, FPRCH8000-02, and H749396118000, along with specific serial numbers.
The ICEfx Cryoablation System is a portable, helium-free desktop medical device used for cryoablation procedures. Incorrectly tightened end caps on the desiccant tube subassemblies could affect proper device operation.
If you own or use one of the affected units, contact Boston Scientific immediately for further guidance. Do not use the device if you believe it may be affected by this recall.
The recalled product
- Product
- ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
- Manufacturer
- Boston Scientific Corporation
- Hazard
- loose-end-caps
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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