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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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.
Medtronic on 5 October widened its 2019 recall of MiniMed pump models 630G and 670G because there’s a chance they can over- or under-dose patients. It also expanded an unrelated 2018 recall of remote controllers used with specific MiniMed pumps due to cybersecurity concerns.