StarTribune – July 9, 2022 – By Burl Gilyard
The company spent five years developing updates that were never completed, derailed by FDA recalls and life-threatening manufacturing defects.
Five years after Medtronic’s billion-dollar purchase of HeartWare International, the company discontinued the device at the center of acquisition — a miniaturized, implantable heart pump — with no clear plans for ever selling it again.
Despite pulling it from the market one year ago, Medtronic is still dealing with the fallout from the device’s shortcomings, including lawsuits, ongoing regulatory recalls and media investigations.
The HeartWare Ventricular Assist Device (HVAD) was designed for patients battling severe heart failure. Once the market leader, HVAD is now associated with a number of life-threatening manufacturing defects that resulted in serious adverse patient events, including at least 14 deaths.
Several medical technology experts said it was surprising HeartWare remained on the market as long as it did.
“I think the question [at the time] was, ‘Why hasn’t it been pulled from the market yet?'” said Madris Kinard, CEO of Pennsylvania-Based Device Events. “When it happened we were thinking, ‘Of course. This needed to happen.'”