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Home » FDA designates new Medtronic HVAD pump implant recall as Class I

FDA designates new Medtronic HVAD pump implant recall as Class I

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A Medtronic HVAD pump opened up to show the inner workings
Medtronic is recalling HVAD pumps for weld defects that could cause serious injury or death. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death.

The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 serious recalls for the Medtronic devices since 2014.

Fridley, Minnesota–based Medtronic halted sales and new device implantations in a Class I recall a year ago following complaints that the internal pump may fail or delay to restart.

Medtronic identified the new problem with pump weld defects this spring while investigating suspected cases of pump thrombosis in three patients, two of which died after their heart pumps were exchanged.

Get the full story at our sister site, Medical Design & Outsourcing.

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About Jim Hammerand

Jim Hammerand is the managing editor of Arrowfly's MassDevice and Medical Design & Outsourcing, where he leads coverage of medtech innovation, design, engineering and manufacturing. He also contributes to our Devicetalks podcasts and live events. Hammerand has more than two decades of journalism experience spanning newspapers, magazines, websites, live events, radio and TV news. For nearly a decade, Hammerand reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then as managing editor of the Puget Sound Business Journal in Seattle. He holds degrees in journalism and management from the University of Minnesota and has won journalism awards from the Society of Professional Journalists, American Society of Business Publication Editors, and Trade, Association, Business Publications International. Connect with him on LinkedIn or by email at [email protected].