(READ) FDA urgent alert on Heartware Ventricular Assist Device after 14 deaths

A dangerous medical device, an internal pump, is being pulled from the market by its maker, Medtronic.

That’s according to a new announcement from the FDA. Although the Heartware Ventricular Assist Device device received FDA approval as “safe and effective,” the agency now admits:

  • There is an increased risk of neurological adverse events and mortality associated with the internal pump.
  • There is a potential for the internal pump to stop. If the internal pump stops, it may delay restarting or fail to restart.
  • Both problems may lead to death or serious injuries. 

Approximately 4,000 patients still have the potentially deadly implants; 2,000 in the U.S., according to the FDA.

According to Medtronic: There are “over 100 complaints involving a delay or failure to restart of the HVAD internal pump, which led to a total of 14 deaths and 13 pump removals.”

Read the full FDA information at the link below:


Read the “urgent” letter to health care providers from Medtronic below:


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