HeartMate II and 3 LVADs Recalled Due to Potential for Outflow Graft Obstruction

Fourteen people have died and 273 have been injured as a result of biological material building up over time in the grafts connecting both HeartMate II and HeartMate 3 left ventricular assist device (LVAD) systems, according to a tally reported by the US Food and Drug Administration.

Abbott/Thoratec Corporation recalled the devices due to what it is calling extrinsic outflow graft obstruction. Announcing the recall last week, the US Food and Drug Administration deemed it Class I, the most serious type.

The action affects several models distributed starting April 21, 2008, and involves 13,883 devices.

Both HeartMate II and the newer-generation HeartMate 3 are used for ventricular support in adults with severe LV heart failure. Extrinsic outflow graft obstruction can occur when biological material builds up between the HeartMate outflow graft and the bend relief (a stiff tube graft guiding the outflow graft) or other components that were added during surgery, an FDA press release explains.

“This buildup can obstruct the device, making it less effective in helping the heart pump blood,” the agency’s announcement reads. “It can trigger alarms indicating low blood flow and affect the device's ability to help the heart properly. The accumulation of biological material typically occurs over 2 years or more.”

In an Urgent Medical Device Correction Letter sent by Abbott on February 19, 2024, the company instructs customers using the LVADs to “pay attention to low-flow alarms, as this is the first symptom of significant outflow obstruction” and provides guidance on diagnosing any unresolved low flow related to outlflow graft obstruction. There is no need to return any product to Abbott, the letter specifies.