10 Medtech Recalls that Shocked the Industry—HVAD10 Medtech Recalls that Shocked the Industry—HVAD
September 17, 2015
HeartWare's HVAD Ventricular Assist Device has been the subject of a number of recent recalls, described in a June 2015 company release. The HVAD is implanted in patients with severe heart failure.
One recall involved an alarm battery failure. This meant that if the HVAD was disconnected from its power sources, the alarm did not sound. According to the FDA recall Web page, there were three injuries and one death reported to be related to this issue.
Another recall involved the HVAD's driveline, which extends from the pump within the patient's body to an external controller and external power. This driveline needs to be handled carefully, because "severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death," according to FDA. The agency's recall description states that this flaw was reported to be related to one serious injury and two deaths.
[Image courtesy of HEARTWARE, INC.]
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