Heartmate II LVAS Pocket Control Recall Issued Following Deaths, Malfunctions

Following at least 26 patient deaths, a recall has been issued for about 29,000 HeartMate II Left Ventricular Assist (LVAS) pocket system controllers due to a risk of malfunction after patients attempt to change the controller while not in a hospital setting.

The FDA announced the HeartMate II LVAS Pocket System Controller recall on May 23, warning that the manufacturer, Abbott Laboratories’ Thoratec subsidiary, has received at least 70 reports of problems where the device malfunctioned after patients tried to change the controller improperly or too slowly. The problems resulted in at least 26 deaths and 19 injuries.

The controller provides a power supply for LVAS system, which is designed to circulate blood through the body when the heart is too weak to do so on its own. It connects to a driveline, which leads under the skin. It either runs off batteries or is connected to a power supply.

According to the FDA, the controller sometimes needs to be exchanged for another controller, and all of the incidents appear to have occurred when patients attempted to do so themselves, while not in a hospital. Many of the patients are elderly or infirm, and in cases where they attached the controller incorrectly or took too long to do so, serious injuries and deaths have occurred.

Abbott-Thoratec first sent out an Urgent Medical Device Correction letter to affected customers on March 29, announcing it was providing new hardware and software to make changing the devices easier in emergency situations. The FDA has now classified that action as a Class I recall, the most serious recall classification, indicating that problems with the device can result in serious injury or death.

The recall affects 28,882 HeartMate II Left Ventricular Assist (LVAS) Pocket System Controllers with model/item numbers 105109, 106015, 106762, and 107801. They were manufactured between July 2012 and December 2016, and distributed from July 2012 to March 2017.

The devices are not being pulled from the market, however. Instead, the company is providing patients with a fully upgraded system with new yellow alignment markings and new drivelines. Existing patients will receive updated software and alarm guides for both primary and backup controllers. For patients with old or damaged controllers, Abbott-Thoratec will send them a new one.

Concerns over the HeartMate II first began to surface following a study in 2012, and the FDA warned of problems with the Heartmate II in August 2015 in a safety communication. At that time, the agency warned that the devices were linked to high rates of bleeding, blood clot complications, strokes and other serious injuries. The warning also included problems by Medtronic’s HeartWare LVAS.

Last month, the FDA also announced a recall for MedTronic HeartWare controllers, due to risks of power and data failures and premature wearing of the alignment guides.

The FDA is calling for healthcare professionals and patients to report any adverse events associated with these devices to its MedWatch Safety Information and Adverse Event Reporting Program.