The trouble with HVAD doesn’t seem to end for Medtronics, an American Medical devices firm. The company’s HVAD, or the Heartware Ventricular Assist Devices, has been in the news for the wrong reasons. Last year, the company was forced to recall the HVAD machines.
The controversial move was after the FDA received information that more than 3,000 deaths were due to different types of problems with the device.
The company had to recall 420-plus batteries after a reported welding issue resulting in severe injuries and death.
Now, the firm informs us there have been around six injuries and death that are related to issues with the batteries powering the HVADs.
“If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death,” said an official statement from the FDA while talking about the latest incident of HVAD recall.
Although the company has acknowledged two deaths via e-mail, they have yet to respond to the total number of HVAD deaths officially.
Medtronics initiated the recall of HVAD in June last week. According to more details by the firm, physicians will be inspecting the components of the device during their clinic visits.
The HeartWare Ventricular Assist Device System is leveraged to assist the heart in constantly pumping blood to the other parts of your body.