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Medtronic Pulls HeartWare Devices After Higher Risk Of Death Compared To Abbott’s HeartMate 3

The company had issued two recalls in the past few months for the device due to recorded deaths and adverse events, but after further analyses has decided to pull it off the market altogether.

An illustration of Medtronic's HeartWare device being worn and a photo of the pump
• Source: Medtronic

Medtronic plc has decided to pull its HeartWare ventricular assist device (HVAD) after a couple of recent recalls and slew of deaths associated with the product. The company is working with rival Abbott to get patients an alternative device.

The US Food and Drug Administration had already notified the public of two class I recalls for the HeartWare intrapericardial centrifugal left-ventricular assist device (LVAD) for advanced heart-failure patients after Medtronic recorded a number of deaths and serious injuries. The first recall was due to faulty pump implant kits, while the second had to do with the device’s connector plugs

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