Medtronic heart pump recalled again after link to 4 patient deaths

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The FDA issued another class 1 recall of Medtronic's HeartWare HVAD ventricular assist device after discovering a design issue that has caused four patient deaths, Medtech Dive reported. 

The FDA said the device has issues that can cause the outflow graft to tear and the strain relief screw to break before the heart pump is implanted. The agency said the issue "may cause serious patient harm, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death.​"

The HeartWare HVAD ventricular assist device is used to help keep blood pumping in patients with end-stage heart failure. 

Medtronic has received 92 complaints related to the issue and four deaths have been reported as of March 5, according to Medtech Dive. The recall covers almost 5,000 devices distributed in the U.S. between March 2018 and April 2020. 

More than a dozen class 1 recalls have been issued by the FDA on the HeartWare device since 2014. Class 1 is the most serious type of recall issued by the FDA, meaning the device can cause death. 

The FDA posted a class 1 recall about the same device in March detailing a separate problem that caused one patient death. 

Medtronic didn't pull the devices from the market, but  advised users to follow additional steps in its instructions for use, Medtech Dive reported. 

"Medtronic is working with regulatory agencies for approval on a design change that is intended to reduce the risk of damage during assembly of the outflow graft and strain relief and attachment onto the pump," a company spokesperson told Becker's Hospital Review. "Medtronic will provide training on this design change after the necessary regulatory approvals are obtained."

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