Boston Scientific Recalls Lotus TAVR Device
Boston Scientific recently issued a voluntary recall for their Lotus transcatheter aortic valve replacement device due to problems with the device locking mechanism. The reported malfunction stems from the premature release of the pin that connects the Lotus valve to the device’s delivery system due to a manufacturing error that added additional pressure to the pin mechanism. Similar to the locking mechanism problem with the next-generation Lotus Edge device resolved in January 2017, Boston Scientific anticipates the issue to be resolved quickly and expects the device to return to markets later this year.
Read more on the issue here.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention
Keywords: Heart Valve Prosthesis, Medical Device Recalls, Transcatheter Aortic Valve Replacement
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