We provided an Important Medical Device Advisory notice to customers regarding incorrect insertion of the HeartMate 3™ modular cable into the HeartMate 3 Left Ventricular Assist System controller.
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.
Urgent Medical Device Recall: HeartMate 3 Outflow Graft Leak (C-Ring) – 30 March 2019
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 May 28, 2018, we provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 (HM3) 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.
MAT-2105167 v1.0
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