Boston Scientific recalled two UPN configurations of the LGX Preconnect with TENACIO Pump without InhibiZone due to potential inflation and deflation performance issues. The devices were distributed worldwide, including the US and Canada. Healthcare providers are instructed to stop use and follow manufacturer 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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This device is part of a patient support system used in clinical settings for inflation/deflation control. It is not a consumer-grade device.
An inflation/deflation performance issue could compromise device function and patient safety by affecting timely inflation or deflation.
This recall is not part of a broader industry pattern.
Immediate cessation of use is required. Delays in treatment could occur while awaiting guidance from the manufacturer.
UDI-DI numbers, lot numbers, and UPNs appear on device labeling and packaging.
Recall remedies or replacements, if offered, typically follow manufacturer guidance. Expect updates by letter.
Keep copies of recall notices, device labels, and all correspondence with the manufacturer
Model numbers and identifying details: UPN 72404405 (12CM IP) with UDI-DI 00191506021252; Lot numbers 1100687060, 1100687061. UPN 72404407 (18CM IP) with UDI-DI 00191506021276; Lot numbers 1100676894, 1100676895. Distribution: Worldwide distribution including US Nationwide and Canada. Sold as part of the LGX Preconnect system. Quantity: 0 units.
No injuries or incidents have been reported.
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