Medtronic HVAD System Manual and Instructions Recalled After Causing 1 Death and 64 Injuries
FDA – A news report published on cardiovascularbusiness.com, states that the U.S. Food and Drug Administration has announced that medical device maker Medtronic has initiated a recall of its HeartWare Ventricular Assist Device (HVAD) System’s instructions. The FDA has classified the recall as a class one recall, which means the medical device Has a problem that may lead to serious injury or death. The news report states that the FDA has received reports concerning one fatality and approximately 64 injuries link to the recalled medical device instructions and patient manual.
The updated patient manuals and instructions for the use of already been drafted and finalized and will be sent to all affected customers, and the FDA stated and its announcement.
The safety issues also are related to the carrying case, controller power-up sequence, and driveline cover. According to the FDA’s recall announcement, dropping the carrying case could damage the case, interrupting the pump’s power supply. The patient manual and instructions for use were updated to provide new information regarding this potential situation.
The FDA report states that the driveline cover may be inadvertently put on backward by the patient, and this potential scenario has also been addressed in the revised patient manual. In addition, the controller unit’s LED lights which turn red when the system is powered up, could be mistaken as a serious alarm, although that is not what the lights indicate. This has been updated in the revised documentation.
According to the news report, the recall will affect over 130,000 devices distributed throughout the United States from March 2006 to the present date. These specific components that are affected by this recall include the controller, HVAD pump, D.C. adapter, A.C. adapter, battery pack, and data cable.
The news report states that Medtronic initially recalled the system back in February 26, 2020. At that time, the company issued an urgent notice to all of its customers who would’ve been at risk by the issue in that recall.
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