Thoratec HeartMate II Left Ventricular Assist System

The Thoratec HeartMate II Left Ventricular Assist System, manufactured by Thoratec Corporation, is a small blood pump that was approved in April 2008. It has been used in children, women and small men to help pump blood throughout the body while they await a heart transplant.

On October 24, 2008, Thoratec Corporation initiated a mechanical heart recall for their HeartMate II Left Ventricular Assist Systems (HM II LVAS), with catalogue numbers 1355 to 102139 which have been distributed since clinical studies began in November 2003. According to the Thoratec press release posted to the FDA's website, over time the wear and fatigue of the percutaneous (needle puncture) lead connecting the HeartMate II LVAS blood pump with the system controller could cause damage that may cause the pump to malfunction. Replacement of the pump would require a second operation that could result in serious injury or even death to the patient.

Since the clinical trials in 2003, approximately 1,972 people have had these artificial hearts implanted, and it is estimated that a significant number of these people could be damaged due to the lead.

The estimated need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months. Thoratec has confirmed that at least 27 of these leads caused the pump to malfunction, and lead to pump replacement surgery. All of the 27 patients survived the surgery. However, in five cases, pump replacement was not possible, and the patients died. The leads now being recalled were distributed to 153 hospitals and distributors throughout the U.S., Europe, Canada and other countries.

According to the press release posted on the FDA's website, "Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter."

Thoratec will also revise its labeling to include updated risk information on the percutaneous lead damage. Patients who have been implanted with a HeartMate II LVAS should contact their doctors immediately to determine the wear and fatigue of the lead, as well as proper instruction on its management and care.

At Reyes Bartolomei Brown, we have worked with many individuals and families who have been injured by a dangerous product. If you or a loved one has suffered injury, or a family member has died as a result of the implantation of the Thoratec HeartMate II Left Ventricular Assist System and the malfunction of its pump, fill out our questionnaire to the right of this page for a free consultation.

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