Cryoablation systems recalled over desiccant tube caps that were not tightened
ICEfx Cryoablation Systems are recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. 18 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes an assembly issue without stating any patient consequence.
Plain-English summary
The ICEfx Cryoablation System, a portable helium-free desktop cryoablation unit, is being recalled under material numbers FPRCH8000, FPRCH8000-02 and H749396118000, with serial numbers including ICP0305, ICP0369 and ICP0338. The recall covers 18 units distributed in the United States and in Canada, France, Germany and Italy.
The recall was issued because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. The FDA classified the action as Class II. The notice does not describe a further consequence.
Hospitals operating these systems should follow the manufacturer's instructions for inspection or correction.
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
- assembly-defect
- cryoablation
- class-ii
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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