The US Food and Drug Administration (FDA) has classified the recall of the Medtronic HeartWare HVAD batteries as Class I, the most serious type of recall which could lead to injuries or death.
The HeartWare Ventricular Assist Device (HVAD) batteries (model number 1650DE) have been recalled by Medtronic due to the possibility of electrical problems that may lead to sudden failures.
In such a case, the batteries may not be able to power the controller, may not be able to accept a charge from the battery charger, or may appear to be charged while in operation.
According to FDA, if the battery fails and the patient is unable to replace the failed battery with a charged, functioning battery, or with AC or DC power, the HVAD may stop functioning. This in turn can result in severe injuries or death.
The medical technology started the recall on 28 June, 2022, and has since recalled 23,372 devices that were sold between January 1, 2009, and the present.
In relation to the problem, Medtronic has recorded 1,159 complaints, six injuries, and one fatality.
The HVAD System assists the heart in continuing to pump blood to the body using batteries, AC or DC power.
It is utilised as a bridge to cardiac transplants, for the recovery of heart tissue, or as destination therapy (DT) in patients for whom heart transplants are not anticipated.
Last month, Medtronic announced that it is expanding its Health Equity Assistance Program for colon cancer screening in medically underserved communities across the US.
The American Society for Gastrointestinal Endoscopy (ASGE) and Amazon Web Services’s (AWS) Health Equity Initiative are supporting the move.
