FDA Recalls Thoratec’s Left Ventricular Assist System

The U.S. Food and Drug Administration (FDA) announced a Class I recall today on Thoratec Corp.’s HeartMate II Left Ventricular Assist System (LVAS). The Pleasanton, Calif.-based company has had the LVAS on the market from February 2010 to February 2012, which is when the recall was initiated.

Thoratec bills the HeartMate II as “one of the most advanced devices to treat advanced heart failure available today.” The device consists of an LVAD (left ventricular assist device) that is designed to assist flow of blood through the body controlled by the heart muscle. Because of its small size (less than a pound in weight), the company claims that the HeartMate II is appropriate for people of many sizes and ages, and that the device is able to work for a number of years once implanted. The company fact sheet cites a survival rate for those who use the device of up to six times greater than medical therapy alone can provide.

In its recall announcement, the FDA describes the HeartMate II as a “bridge to transplantation in heart transplant candidates at risk of imminent death from non-reversible left ventricular failure.” People who are not transplant candidates are also able to use the device if they are classified as New York Heart Association (NYHA) class IIB of IV end-stage, left-ventricular failure. The NYHA classifies the severity of heart disease based in limitations on physical activity and objective evidence of heart disease, with class IIB being slight activity limitations accompanied by structural heart disorder.

The HeartMate II is being recalled due to a problem with the bend relief on the device. It has been known to detach from its intended position. It should wrap around the proximal outflow graft; if it moves out of position, the bend relief opens the graft up to damage (including perforation), thereby reducing blood flow or causing blood clots. Also, the metal end of the bend relief is quite sharp, risking erosion of the graft. This can cause serious further health problems or death.

The actual HeartMate II systems are not being physically recalled, despite the FDA’s label.

Thoratec spokeswoman Susan Benton called it a “correction” instead of a recall—those who have the devices implanted already will continue to use them. However, Thoratec has informed the FDA that they have revised the labeling of the device and clinicians have been directed to follow these revised instructions to make sure the bend relief is properly engaged.