June 17, 2015 — The FDA has issued a Class I recall for the HeartWare Ventricular Assist System because a defect could cause the pump to stop working, resulting in serious patient injury or death.
The HeartWare VAS is a pump that helps deliver blood from the heart to the rest of the body. It is known as a “bridge to transplant” because it is used in patients who have end-stage left ventricular heart failure and are waiting to receive a heart transplant.
The problem is that the alignment guides to the power supply connector ports can wear out over time, causing the connection pins to become twisted or bent. Eventually, the problem could interfere with the connection between the controller and the device, causing the pump to stop.
According to the recall:
“An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. The company has reported 33 reports of malfunction and one serious injury related to this problem.”
HeartWare also issued a recall in March, which affected 120 patients in the United States who received older controller models — product codes 1400 and 1401XX — as part of the ADVANCE and ENDURANCE clinical trials. HeartWare has made design changes to the newer controllers to improve immunity to electrostatic discharge, the company told Medscape.
This is not the first time HeartWare has had problems with the device. Last year, the FDA sent the company a warning for failing to take appropriate measures to correct complaints or design defects. The company received 27 complaints related to controller failure over a 3-year period, including four serious injuries and two deaths. The problem was blamed on electrostatic discharge.
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