Boston Scientific recalled 59 units of the TENACIO Pump with InhibiZone on September 11, 2025. The recall addresses potential inflation and deflation performance issues. Patients should stop using the device immediately and follow the manufacturer's instructions.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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 recalled product is the TENACIO Pump with InhibiZone, UPN: 72404429. It was distributed worldwide, including the United States and Canada.
The recall warns of potential inflation and deflation performance issues. These issues can affect the device's effectiveness.
No specific incidents or injuries have been reported at this time. The risk level is classified as high.
Stop using the pump immediately. Follow the recall instructions provided by Boston Scientific Corporation or contact your healthcare provider for further guidance.
For further instructions, contact Boston Scientific Corporation. Their website is available for additional information.
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