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.
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After a flurry of recalls related to its HeartWare Ventricular Assist Device System, Medtronic says a backup controller with modified software is now available in the event of a pump failure for hospitals using the system.
The US Food and Drug Administration is advising health care providers that patients with the Medtronic Heartware Ventricular Assist Device (HVAD) System are at risk from potential device malfunction.
The Chairman of the US House Subcommittee on Economic and Consumer Policy is pressing the FDA on why it allowed what he says is a dangerous medical device to stay on the market for so long.