An urgent Medical Device Correction was issued on October 22, 2021, communicating that the HeartMate Touch™ Communication System Application is unexpectedly closing or failing to open.
On December 2, 2019, Abbott provided an Urgent Medical Device Recall notice to customers regarding inference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3™ Left Ventricular Assist System.
On March 30, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did not tighten completely.
On March 7, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a physician observed a small black plastic particle in the left ventricle during the implant procedure after using the HeartMate 3 Coring Tool. Investigation into this issue has confirmed that the particle came from the Coring Tool’s plastic blade cover.
On October 17, 2018, Abbott provided an update to physicians on the previously communicated Class I Recall associated with the HeartMate 3 Left Ventricular Assist System. Abbott has received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice.
On May 22, 2018, FDA classified this medical device advisory as a Class I Recall. Abbott provided a Frequently Asked Questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall.
On May 21, 2018, Abbott provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
On April 5, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.
