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FDAnews Device Daily Bulletin

HeartWare Issues Recall for Ventricular Assist Device Pumps

Oct. 25, 2016

HeartWare has issued a recall for its HeartWare Ventricular Assist Device pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source. If the driveline were to become contaminated, it could cause electrical issues or a pump stoppage.

The HVAD assists in delivering blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant.

There were 105 units distributed nationwide. Manufacturing dates are March 17, 2006, through June 27, 2016, with all serial numbers lower than HW25838. — Cynthia Jessup

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