Abbott’s Latest HeartMate LVAD Recall Linked to 14 Deaths

The U.S. Food and Drug Administration has identified Abbott’s recall of its HeartMate II and HeartMate 3 left ventricular assist system (LVAS) as Class I.
 
The recall was made because of an issue called extrinsic outflow graft obstruction (EOGO). This occurs when biological material builds up between the HeartMate outflow graft and outflow graft bend relief, or additional components added during surgery.
 
The buildup in the systems can obstruct the device, rendering it less effective in helping the heart to pump blood. The device can trigger alarms indicating low blood flow and impact its ability to help the heart pump blood properly. This accumulation usually occurs over two or more years.
 
FDA said this recall is a product correction, not a removal. Abbott has reported 273 injuries and 14 deaths associated with the issue.
 
The HeartMate II and HeartMate 3 LVAS help the heart pump blood when it’s unable to do it effectively on its own. The devices are used in short- and long-term support in adults with severe left ventricular heart failure. They can be used while waiting for a heart transplant, to help the heart recover, or permanently when a transplant isn’t viable. HeartMate 3 can be used in pediatric patients.
 
The devices work by taking over the left ventricle’s pumping function. They divert blood from the weakened left ventricle and propel it into the aorta to help circulate blood. The devices can be used inside and outside the hospital.
 
Abbott sent all affected customers an Urgent Medical Device Correction Letter in February. It requested customers to complete and return an acknowledgement form included with the letter, and the company said it will continue to send letters to new consignees until corrective measures are in place.
 
The company urged users pay attention to low flow alarms, because they’re the first sign of a significant outflow obstruction. Further guidance was also provided about how to diagnose unresolved low flow associated with the outflow graft obstruction.