Patient Deaths Prompt Class I Recall of Thoratec HeartMate II Pocket Controllers
Medical device recall issued by FDA following reports of injuries and deaths linked to Thoratec’s HeartMate II Pocket Controller.
The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the Thoratec HeartMate II pocket controller, following reports of at least four deaths and five serious injuries potentially caused by the device. The FDA recall comes after a notice issued last month by Thoratec warned about injuries and deaths associated with its HeartMate II pocket controller, and the Class I category, the most serious recall classification the FDA can assign, means the agency believes there is a reasonable probability that the controller may cause adverse health consequences, including death. If you or a loved one has suffered injuries allegedly caused by a defective medical device, our consumer advocates at the Leading Justice can help put you in touch with a product liability lawyer who has experience handling product injury cases.
Patients Not Adequately Trained to Use New Controllers
According to the FDA’s medical device recall, all of the injury and wrongful death reports received to date appear to have involved patients using HeartMate II Left Ventricular Assist System Pocket Controllers, whose devices were originally linked to an older model of the controller. Apparently, patients trained to use the older EPC System models are experiencing difficulty switching from the main controller to the backup controller when using the new model. According to the FDA, these patients were transferred from the EPC System Controller to the new Pocket System Controller without receiving adequate training regarding how to connect to the new controller, which may increase their risk of suffering serious injury or possibly even death.
HeartMate II Devices Affected by Recall
The HeartMade II LVAS is a coronary device implanted in patients whose hearts are too weak to efficiently pump blood to the rest of the body, and is widely used among patients with advanced heart disease who are waiting for a heart transplant. The pocket controller monitors the implant and warns patients if the battery charge is running low, and a new version of the controller was introduced in the United States in May 2013, currently used by 2,142 patients. The HeartMate II product recall affects the following devices:
- HeartMate II LVAS Implant Kit with Pocket Controller: Catalog Numbers 106015 and 106016
- HeartMate II LVAS Pocket System Controller: Catalog Numbers 106762 and 106017
- HeartMate II LVAS Pump and Pocket Controller Kit: Catalog Number 107801
- Pocket System Controllers removed from packaging: Catalog Number 105109
Pocket Controllers May Fail to Function Properly
The FDA recall of the HeartMate II pocket controller comes after a November 2013 study found an increased risk of blood clot-related problems with the Thoratec HeartMate II. Even after receiving reports of patient injuries and deaths linked to its HeartMate II pocket controller, Thoratec failed to issued a product recall, claiming that there is nothing wrong with the device and that it isn’t defective. The FDA obviously disagrees, having issuing a Class I recall of the devices along with this warning: “The design differences between the EPC Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function.”