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 reported strong growth for the past quarter, with CEO Geoff Martha emphasizing the medtech giant’s efforts in M&A and R&D.
12 Deaths Prompt Another Class I Recall For Medtronic’s HeartWare – The Firm’s Fourth In Recent Weeks
The medtech giant has racked up yet another high-risk class I recall designation from the US FDA, this time for HeartWare Ventricular Assist Device (HVAD) cables and controller ports. It’s also the second class I recall action for the HeartWare device in a little more than six weeks, and the company’s fourth overall.
Digital Health Roundup, May 2021: Immersive Technologies In Surgery Suite, ‘Smart’ Toilets And Pills, New SaMD Cybersecurity Standards
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news from May.