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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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.
The medtech giant yanked from shelves in July its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The recall was labeled high-risk class I by the US FDA on 20 September. It’s the company’s ninth class I this year.
Medtronic’s Angiographic Guidewire Component, distributed since 2007, was recalled because the devices weren’t sterilized. It’s the company’s eighth class I recall this year.