The U.S. Food and Drug Administration (FDA) announced March 1 that Medtronic has issued a Class I recall of their HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits, because the device may not initially start or restart, or it may have a delay in restarting after the pump was stopped. These issues may lead to "serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death."

To date, the FDA has received 29 complaints about the device, including reports on two deaths, 19 serious injuries, and eight cases of patients who had a life-threatening event but recovered without long term effects.

The HVAD Pump Implant Kits are part of the HeartWare HVAD System. Read the full FDA announcement for instructions on next steps and to get details on affected device lots and numbers.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: ACC Advocacy, Heart-Assist Devices, Heart Failure, United States Food and Drug Administration

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