Boston Scientific recalled one CX Preconnect with TENACIO Pump due to inflation and deflation performance issues. The recall affects models UPN 72404486 and UPN 72404488 distributed in the US and Canada. The recall was issued on September 11, 2025, and remains active as of October 22, 2025.
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 models are UPN 72404486 (15CM IP) and UPN 72404488 (21CM IP). The units have UDI-DI numbers 00191506021658 and 00191506021672, respectively. They were distributed worldwide, including the US and Canada.
The CX Preconnect Pump may experience issues with inflation and deflation performance. This malfunction can pose significant risks, including inadequate fluid delivery.
No specific incidents or injuries have been reported at this time. However, the potential for performance issues raises concerns regarding patient safety.
Stop using the device immediately. Follow the recall instructions provided by Boston Scientific or consult your healthcare provider for further guidance.
For more information, contact Boston Scientific Corporation. Visit their website or call their customer service line.
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