Thoratec HeartMate II Pocket Controller Recall Issued After Deaths

The FDA has determined that a warning issued by last month by Thoratec regarding injuries and deaths linked to it’s HeartMate II pocket controller constitutes a class I medical device recall, the most serious recall classification the agency can assign.  

An Urgent Medical Device Correction Letter regarding a risk of problems with Thoratec HeartMate II pocket controller was issued on March 4, following reports of at least four deaths and five serious injuries that may have been caused by the device.

The categorization of the action as a class I recall suggests that the FDA believes there is a reasonably probability of adverse health outcomes or death if the controller is used.

All of the reports received to date appear to have come from patients with HeartMate II Left Ventricular Assist System (LVAS) Pocket Controllers, whose device was originally linked to an older model of the controller.

It appears that patients trained to use the older EPC System models are having problems switching from the main controller to a backup controller if they are using the new model. According to the FDA, the patients were switched from the EPC System Controller to the new Pocket System Controller without adequate training on how to connect to the new controller.

Thoratec did not issue a recall following the reports, saying that there is nothing wrong with the device and that they are not defective. However, the FDA indicates that the “use of this product may cause serious adverse health consequences, including death.”

“The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected,” the FDA warns. “If the controller is not properly connected, the device cannot function.”

The recall affects the following devices:

• The HeartMate II LVAS Implant Kit with Pocket Controller: Catalog Numbers 106015 and 106016
• The HeartMate II LVAS Pocket System Controller: Catalog Numbers 106762 and 106017
• The HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801
• Pocket System Controllers removed from packaging: Catalog Number 105109.

The Thoratec HeartMate II LVAS is a coronary implant given to patients whose hearts are too weak to efficiently pump blood. Former Vice President Dick Cheney is perhaps the most famous recipient, but they have been widely used among individuals with advanced heart disease who are waiting for a heart transplant or are too weak to undergo such a procedure.

The controllers monitor the HeartMate II and warn patients if the battery charge is running low. The company released a new version of the pocket controller in August 2012 in Europe, and then in the United States in May 2013. The company states that 2,142 patients have received the new controller.

The company advises patients with the pocket controller to immediately contact their doctor for re-training on the use of the device and to receive an updated Patient Handbook. The company also advises doctors who prescribe the system to review the updated labeling and training materials.

This is the latest concern surrounding the Thoratec HeartMate II, which has been linked to a potential risk of blood clots in recent months.

A study published in November 2013 highlighted recent increases in the number of blood clot-related problems with the Thoratec HeartMate II that have been seen since March 2011. After examining data from three different hospitals, researchers from Cleveland Clinic were able to identify that over the past few years there has been an increase in the rate of clot formation during the months after the HeartMate II was implanted, confirming what doctors at the hospital suspected based on their own experiences.

The manufacturer has denied that any changes were made to the device and indicate that the small study does not accurately portray the device’s performance. In January 2014, a Thoratec HeartMate II class action lawsuit was filed by investors who say the company withheld important information about the safety and efficacy of the device, which has caused the stock price to decline.