The Medical Device Business Journal — Medical Device News & Articles | MassDevice

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.

Filed Under: Blog, Cardiac Implants, Cardiovascular, Implants, News Well, Recalls, Regulatory/Compliance Tagged With: FDA, Medtronic

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