The US Food and Drug Administration has declared Medtronic’s recent recall of batteries, power, and data link cables and other peripheral equipment for its Heartware Ventricular Assist Device (HVAD) System as class I, the most serious category of safety alert, agency announced today.
The recall, which the company announced to affected healthcare providers and patients on February 26, was said to involve 106,366 individual HVAD devices manufactured since March 2006.
It was initiated because of “risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the controller port metal pins (for example, bent pins).”
The issues could impair the pump’s operation or keep it from working altogether, with a potential for serious patient harm, including death, the FDA said.
There have been 855 complaints regarding such issues with the HVAD components, it noted, including 8 reports of injuries and 12 deaths.
The Heartware HVAD was initially approved in the US in 2012 for bridge-to-transplantation use; it was introduced in Europe for that indication in 2009. The agency approved it for destination therapy in 2017.