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12 Deaths Prompt Another Class I Recall For Medtronic’s HeartWare – The Firm’s Fourth In Recent Weeks

 
• By Shawn M. Schmitt

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.

Medtronic building.

Only a little more than six weeks separates two high-risk class I designations by the US Food and Drug Administration for recalls of Medtronic PLC’s HeartWare device.

The latest class I, announced by the agency on 15 April, comes because of “risk of wear and tear of...

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More from Policy & Regulation

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• By Ashley Yeo

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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
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