Boston Scientific recalled 19 ICEfx Cryoablation System units worldwide, including the United States, Canada, France, Germany and Italy. The recall concerns desiccant tube subassemblies with end caps that were not tightened. Clinicians and patients should stop using the device immediately and follow recall instructions issued by the manufacturer.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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The ICEfx Cryoablation System is a portable, helium-free desktop cryoablation device used in medical procedures. It is designed for clinical settings and requires professional operation.
End caps on desiccant tube subassemblies were not tightened during manufacturing. This could affect device integrity or introduce desiccant material into the system, potentially compromising sterile barriers.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics must identify affected units and halt use. The recall affects 19 units distributed worldwide, with potential patient safety implications if devices are used before remediation.
Refer to the FDA recall page for Z-2550-2025 and the manufacturer’s recall communications.
Recall remedies are issued by the manufacturer. Processing timelines for replacements or refunds typically span several weeks.
Keep the recall letter, model numbers, serial numbers, and all correspondence with the manufacturer for your records.
Model numbers: FPRCH8000, FPRCH8000-02, H749396118000 Sold worldwide with US nationwide distribution; also in Canada, France, Germany and Italy Quantity recalled: 19 units Manufacturer: Boston Scientific Price: Unknown
No injuries or incidents have been reported.
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