The company has also notified physicians to stop implanting the HVAD system, which is used to treat patients with end-stage heart failure.
A growing body of evidence shows patients implanted with the HVAD pump are more likely to die or experience adverse neurological events, such as a stroke, compared to those implanted with similar devices.
Medtronic has received more than 100 complaints involving the delay or failure to restart the heart pump, including 14 reports of patient deaths, according to an FDA health alert. In another 13 cases, clinicians had to remove the device.
Medtronic is creating a support program for about 4,000 patients worldwide and 2,000 in the U.S. implanted with the heart pump.
To learn more, click here.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
