Abbott/Thoratec Corp. Recalls Heartmate II and Heartmate 3 Left Ventricular Assist System (LVAS) Due to Long-term Buildup of biological material Causing an Obstruction

Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called Extrinsic Outflow Graft Obstruction, (EOGO). This occurs when biological material builds up between certain parts of the device, causing a blockage that makes it harder for the heart to pump blood.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

If you have questions about this recall, contact Abbott/Thoratec Corporation at (844) 692-6367.