Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3

Recall Alert: HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) 

The FDA has issued a Class I recall, the most serious type, for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) due to potential serious injuries or death associated with their use. This recall is classified as a correction, not a product removal. 

Recalled Product 

• Product Names: HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) 
• Model Numbers: See full list of affected devices on FDA recall notice
• Distribution Dates: Starting in April 21, 2008 
• Devices Recalled in the U.S.: 13,883 
• Date Initiated by Firm: February 19, 2024 

Device Use 

These devices are utilized to assist the heart in pumping blood when it is unable to do so effectively on its own. They are used in adult patients with severe left ventricular heart failure, either temporarily while waiting for a heart transplant, to aid in recovery, or as a long-term solution. HeartMate 3 can also be used in pediatric patients. 

Reason for Recall 

The recall is due to an issue called Extrinsic Outflow Graft Obstruction (EOGO), where biological material accumulates between the HeartMate Outflow Graft and other components, obstructing the device and potentially triggering alarms indicating low blood flow. This buildup can affect the device’s ability to assist the heart properly and may result in serious adverse health consequences, including death. 

Actions to Take 

Affected customers have been sent an Urgent Medical Device Correction Letter, instructing them to complete and return an acknowledgment form and pay attention to low flow alarms, as they may indicate outflow graft obstruction. Additional guidance on diagnosis and resolution of this issue has been provided. 

Contact Information 

Customers in the U.S. with questions about this recall can contact Abbott/Thoratec Corporation at (844) 692-6367. 

If you have been using or are receiving care through the HeartMate II or HeartMate 3 Left Ventricular Assist Systems, it is important to take note of this recall and follow the instructions provided to ensure your safety and well-being. 

A list of all affected device models is listed in the FDA recall notice.