HeartMate II® Pocket System Controller Recall
September 12th, 2017|
Do you or a loved one have a HeartMate II® LVAS Pocket System Controller manufactured by Abbott-Thoratec? If so, you should speak with your doctor right away about your next steps, as the device was recalled by the U.S. Food and Drug Administration on May 23, 2017.
The recall was prompted after Abbott-Thoratec received reports of more than 70 incidents, including 19 injuries and 26 deaths. Heartmate II Pocket System Controllers are external power supplies that connect to HeartMate II LVAS pumps, which are implanted heart pumps.
The controllers connect to the pumps via a lead under the skin, and patients are responsible for switching from their main devices to backup devices when necessary. However, the switching procedure can be difficult, and elderly or untrained patients may struggle to perform it. If the switching process takes too long, serious injuries or even death can occur.
Ferrer, Poirot & Wansbrough is here to assist victims of the recalled HeartMate II Pocket System Controller. We believe that all medical device manufacturers should be held accountable when their products injure or pose risks to patients, especially those who may struggle with complicated procedures like switching power supplies.