Boston Scientific recalled the TENACIO Pump on September 11, 2025. The device may exhibit inflation and deflation performance issues. Patients must stop using the pump 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 UPN: 72404420. It was distributed worldwide, including the US and Canada. There are no reported units remaining on the market.
The TENACIO Pump may experience inflation and deflation performance issues. This defect poses significant risks to patients relying on the device.
No specific incidents have been reported, but the potential for performance issues raises serious safety concerns.
Stop using the TENACIO Pump immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, call Boston Scientific at 1-800-XXX-XXXX or visit their website. Follow any additional instructions provided in the recall notification.
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