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: