ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Reported: September 17, 2025 Initiated: August 18, 2025 #Z-2550-2025
Product Description
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Reason for Recall
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 18 units
- Distribution
- Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000. Recalled by Boston Scientific Corporation. Units affected: 18 units.
Why was this product recalled? ▼
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2550-2025.
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