Abbott-Thoratec Issues Recall For HeartMate II LVAS Pocket System Controller
Abbott-Thoratec recently issued a recall for HeartMate II LVAS Pocket System Controller due to exchange malfunctions. The controller, a power supply connected to the implanted HeartMate II LVAS pump that pumps blood throughout the body, is provided to each patient in case of a device alarm or malfunction. Abbott-Thoratec has received 70 reports of device malfunction, including 19 injuries and 26 deaths, all occurring during the process of exchanging controllers outside of the hospital. To mitigate the issue, patients are receiving new software and hardware updates to assist with exchanges in emergency situations. Item Numbers affected include 105109, 106015, 106762, 107801. They were manufactured between July 2012 and December 2016. Read the full announcement from the U.S. Food and Drug Administration here.
Keywords: United States Food and Drug Administration, Prostheses and Implants, Equipment Failure
< Back to Listings