2 Dead In Class I Recall Of Medtronic Stents
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.
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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 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.
King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.