MINNEAPOLIS (WCCO) – Medtronic is stopping distribution and sale of a heart pump system after 14 deaths and 13 removal surgeries were reported, along with 100 other complaints.
Roughly 4,000 patients worldwide use the HVAD System, which was approved in 2012 as a bridge to heart transplants for patients who are at risk of death from heart failure. Some patients also use the device for heart tissue recovery and destination therapy, if a heart transplant is not planned. Medtronic, which has headquarters in Fridley, Minnesota, says 2,000 of the patients live in the U.S.
The company says there was an increase of clinical observations that cited a higher frequency of neurologically adverse events with the system, including stroke and deaths, compared with other available heart pumps.
Previously, the company had issued an alert informing physicians that the pump may experience a delay or failure to restart.
The U.S. Food and Drug Administration also noted that there was a voluntary recall of the device in December of 2020.
Medtronic says they are developing a support program for patients who have had an HVAD system implanted, which includes financial assistance and resources for physicians and caregivers. They are also working with the FDA.
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