FDA Applies Class I Designation to HeartWare Ventricular Assist Device Pump Recall

Larry Hand

Disclosures

October 25, 2016

SILVER SPRING, MD — The Food and Drug Administration (FDA) has classified the recall of the HeartWare Ventricular Assist Device (HVAD) pumps as a class I recall, the most serious[1].

HeartWare began the recall on July 29 because of a design problem with the driveline connector, a tube that connects the HVAD's pump to the external controller and power source. Driveline contamination can lead to fluid or other material getting into the pump and causing electrical issues or stopping the pump, which could lead to death.

The HVAD is used in patients with end-stage left ventricular heart failure, who are waiting for a transplant.

The specific HVADs being recalled have serial numbers lower than HW25838 and product codes 1103 and 1104. They were manufactured between March 17, 2006 and June 16, 2016, with 105 units distributed nationwide.

The device is used in hospital and out of the hospital.

HeartWare sent out an "Urgent Medical Device Recall Letter" August 17 asking customers to identify affected inventory and return affected products to HeartWare. Healthcare providers with questions can contact the company at cs@heartware.com or by calling 877-367-4823.

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