Boston Scientific recalled 19 units of the ICEfx Cryoablation System on August 18, 2025. The recall stems from improperly tightened end caps on certain desiccant tube subassemblies. Patients and healthcare providers should stop using the device immediately.
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
The recalled units include material numbers FPRCH8000, FPRCH8000-02, and H749396118000. These were distributed worldwide, including the US, Canada, France, Germany, and Italy.
The issue involves desiccant tube subassemblies with end caps that were not correctly tightened. This defect poses a high risk to patients using the device.
There are no reported incidents or injuries linked to this recall. No deaths have been reported either.
Stop using the ICEfx Cryoablation System immediately. Follow the recall instructions provided by the manufacturer and contact Boston Scientific or your healthcare provider for further guidance.
For further assistance, contact Boston Scientific Corporation at 1-800-XXX-XXXX or visit their website for more information.
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