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After 2 deaths, FDA issues Urgent Medical Device Correction for Thoratec HeartMate II

Manufacturer of Thoratec HeartMate II Left Ventricular Assist System (LVAS) warns batteries may expire

HMII_FDA_URGENTThe Food and Drug Administration (FDA) recently issued an Urgent Medical Device Correction for the Thoratec HeartMate II Left Ventricular Assist System (LVAS), warning patients the backup battery inside some units’ handheld control systems are subject to expiration dates. The FDA’s Thoratec HeartMate II LVAS warning affects the “Pocket Controller”(PC)  used to monitor the LVAS system.

Thoratec, the maker of the HeartMate II LVAS, admitted two patients died after unsuccessful attempts to switch their HeartMate II LVAS System Controllers from primary to backup controllers when the battery expiration alarm on the HeartMate II LVAS went off. The two patients died after being unable to reconnect their HeartMate II LVAS heart pump to the controller. At least one other patient was seriously injured attempting to switch their System Controller from primary to backup.

The purpose of the FDA announcement is to prevent avertable warning signals which may cause patients to disconnect their HeartMate II LVAS System Controllers. Thoratec says it is working with doctors to identify patients whose HeartMate II LVAS backup batteries may be near expiration.

The Thoratec HeartMate II LVAS is a device designed to help patients at risk of heart failure pump blood through the left side of the heart and throughout the body. The device measures approximately 3 inches long and weighs about 10 ounces. Approximately 20,000 heart patients across the country utilize the Thoratec HeartMate II LVAS.

The product liability attorneys of The Cochran Firm, D.C. are closely monitoring the situation and will continue to update consumers as more information comes to light. If you or a loved one were seriously injured while using a Thoratec HeartMate II LVAS heart pump, contact one of our attorneys for a free legal consultation.



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