Boston Scientific recalled the TENACIO Pump without InhibiZone (UPN 72404420) worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall 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 TENACIO Pump is a medical device produced by Boston Scientific used in infusion-related therapies. The recall concerns inflation/deflation performance issues.
A defect could cause unreliable inflation or deflation, potentially affecting therapy delivery or device function.
This recall is not described as part of a broader industry pattern.
Affected patients may need to discontinue use and seek guidance from their provider. Financial and scheduling impacts may occur for replacements.
Recall letter from Boston Scientific or healthcare provider; device labeling; Boston Scientific website; FDA recall page
Unknown; manufacturer guidance will dictate replacement or remediation timing
Keep the recall notice, preserve device for records, document communications with manufacturer and providers
Model numbers: UPN 72404420; Lot numbers/UDI-DI: 1100720566, 1100720567, 1100720568. Sold worldwide, including the US and Canada. Recall date: 2025-09-11. Manufacturer: Boston Scientific Corporation. Status: Active. Price: Unknown.
No injuries or incidents have been reported.
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