Boston Scientific recalled the LGX Preconnect with TENACIO Pump on September 11, 2025. The recall affects devices sold in the U.S. and Canada due to inflation and deflation performance issues. Consumers should stop using the device immediately and follow provided 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 products include LGX Preconnect with TENACIO Pump, UPNs: 72404405 (12CM IP) and 72404407 (18CM IP). These devices have UDI-DI numbers 00191506021252 and 00191506021276. The devices were distributed worldwide, including the U.S. and Canada.
The devices may experience inflation and deflation performance issues, which can pose significant health risks. This recall is classified as Class II, indicating a high hazard level.
No specific incidents have been reported, but the potential for complications exists. The recall addresses safety concerns related to device performance.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, visit Boston Scientific's recall page or call their customer service. More details are available at the FDA's enforcement report.
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