Boston Scientific recalled one unit of the Preventive Maintenance Kit ICEFX on August 18, 2025. Certain desiccant tube subassemblies had improperly tightened end caps. This recall affects distribution in the US, Canada, France, Germany, and Italy.
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 recall involves the Preventive Maintenance Kit ICEFX, Material Number SPRPM8000, Batch: 108159110. It is distributed worldwide, including the US, Canada, France, Germany, and Italy.
The recall is due to certain desiccant tube subassemblies being built with end caps that were not correctly tightened. This poses a high hazard risk.
No specific incidents or injuries were reported related to this recall. The risk level remains high.
Stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2551-2025.
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