Abbott is recalling its HeartMate II and 3 LVADs, which have been associated with 14 deaths, due to obstruction risks.

Summary: Abbott and Thoratec Corp are recalling 13,883 HeartMate II and HeartMate 3 LVADs in the US due to the risk of extrinsic outflow graft obstruction, where biological material buildup can impede device function, leading to reduced heart support. This condition triggers low-flow alarms and has resulted in 273 reported injuries and 14 deaths. The FDA has categorized this as a class I recall. This follows another recent recall of the HeartMate Touch communication system. 

Key Takeaways:

  • Abbott and Thoratec Corp are recalling HeartMate II and HeartMate 3 left ventricular assist devices due to risks of extrinsic outflow graft obstruction, which can prevent the device from effectively assisting heart function.
  • The obstruction is caused by biological material buildup, leading to 273 injuries and 14 deaths reported so far. This has triggered the FDA to classify this as a class I recall, which indicates the highest level of risk of severe health consequences or death.
  • The current recall follows closely after Abbott’s recall of the HeartMate Touch communication system, which was recalled due to risks that could unexpectedly stop or start the pump.

The US Food and Drug Administration (FDA) announced that Abbott and one of its subsidiaries, Thoratec Corp, is recalling HeartMate II and HeartMate 3 left ventricular assist devices (LVAD) due to the risk of long-term buildup causing an obstruction.

The issue, called extrinsic outflow graft obstruction, happens when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or additional components added during surgery. This buildup can obstruct the device, making it less effective in helping the heart pump blood. 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 two years or more.

There have been 273 reported injuries and 14 reports of death associated with this issue.

The FDA has identified this as a class I recall, the most serious type of recall. 

The recall follows Abbott’s recent recall last month of its HeartMate Touch communication system (version 1.0.32), which monitors patients with an implantable HeartMate 3 left ventricular assist device. The system was recalled due to the risk of unexpected pump stops or starts.

Recalled Product

Device Use

The HeartMate II and HeartMate 3 LVADs are used to help the heart pump blood when it’s not able to do so effectively on its own. The HeartMate II and 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure. It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn’t an option. HeartMate 3 can also be used in pediatric patients.

Both devices work by taking over the pumping function of the left ventricle, the main pumping chamber of the heart. They divert blood from the weakened left ventricle and propel it into the body’s main artery, the aorta, helping to circulate blood throughout the body. The devices are used both inside and outside of the hospital.

What to Do

On Feb 19, 2024, Thoratec Corp sent all affected customers an Urgent Medical Device Correction Letter. 

The letter requested customers to: 

  • Complete and return the acknowledgment form included with the letter.
    • Abbott will continue to send letters to new consignees until the corrective measures are in place.
  • Pay attention to low flow alarms as this is the first symptom of significant outflow obstruction. Additional guidance was provided on how to diagnose unresolved low flow associated with outflow graft obstruction.

Customers in the US with questions about this recall should contact Abbott/Thoratec Corp at 844-692-6367.

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