Boston Scientific recalled 59 Tenacio Pumps with InhibiZone worldwide, including the US and Canada. The devices may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and await 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 with InhibiZone is a medical device used in clinical settings. It is designed to assist in specific implant or therapeutic procedures and is distributed internationally by Boston Scientific.
The device may fail to inflate or deflate as intended, which could compromise performance during use.
This recall is not described as part of a broader industry pattern.
If the device underperforms, patients may require additional medical evaluation or procedures. No injuries have been reported to date, but the recall could affect ongoing treatments.
Identifiers are on the device label, packaging, and recall notice.
Refunds or replacements typically take 4-8 weeks once processed by the manufacturer.
Keep the recall letter, save all communications, photograph labels and serial numbers, and retain proof of purchase when available.
Model numbers: UPN 72404429. UDI-DI/lot numbers: 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139, 1100551145, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590. Sold worldwide, including US and Canada. Sold from: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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