Boston Scientific recalled 172 units of its CXR Preconnect with TENACIO Pump on September 11, 2025. The recall stems from potential inflation and deflation performance issues. The devices were distributed worldwide, including the US and Canada.
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 include UPNs: 72404461 (12CM PS IZ), 72404462 (14CM PS IZ), 72404463 (16CM PS IZ), 72404464 (18CM PS IZ), and 72404465 (10CM IP IZ). The pumps were distributed worldwide, including the US and Canada.
The pumps may experience inflation and deflation performance issues. This could compromise their effectiveness in medical applications, posing significant health risks.
No specific incidents were reported. The recall is classified as Class II, indicating a potential for serious health risks.
Patients and healthcare providers should stop using the devices immediately. Contact Boston Scientific or your healthcare provider for further instructions.
For more information, visit Boston Scientific's website or the FDA recall link. Contact your healthcare provider for guidance.
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