The U.S. Food and Drug Administration (FDA) has announced a Class I recall of Abbott’s HeartMate 3 Left Ventricular Assist System Implant Kit.

“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,” the FDA noted.

“The Class I recall is the second one for Abbott’s HeartMate 3 device this year and follows 70 injuries and two patient deaths,” Medical Device Network stated.

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Per Medical Device Network:

The current recall is the second Class I recall issued by the FDA for the HeartMate 3 system. Earlier this year, the agency issued a Class I recall for Abbott’s HeartMate Touch System, which is used to monitor patients who have an implantable HeartMate 3 device.

The recall was issued after the FDA identified issues with the seal interface between the LVAD inflow cannula and the apical cuff. The seal break allows for blood or air to enter the device which can result in bleeding, right heart failure, longer-than-expected surgery, or an air embolism.

The sealant issues in all the reported events were observed during device implantation. The recall for Abbott’s communication systems is a correction as opposed to a product removal, as per an FDA notice.

Abbott has reported 81 incidents as part of the recall notice, including 70 injuries and two deaths. The recall involves 882 HeartMate 3 left ventricular assist system implant kits, which have been in distribution since 1 March 2021.

“The HeartMate 3 Left Ventricular Assist System (LVAS) is used to help the heart pump blood when it is not able to do so effectively on its own. The HeartMate 3 is used for both short- and long-term support in pediatric and 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,” the FDA stated.

“HeartMate 3 LVAS takes over the pumping function of the left ventricle, the main pumping chamber of the heart. It diverts blood from the weakened left ventricle and propels it into the body’s main artery, the aorta, helping to circulate blood throughout the body. The device is used both inside and outside of the hospital,” the agency added.

From the FDA:

Reason for Recall

Abbott is recalling the HeartMate 3 LVAS after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. In all reported events, the issue was observed during implantation of the device.

Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism. Use of these devices may cause serious injury or death.

Abbott reports 81 incidents, including 70 injuries and two deaths related to this issue.

Who May Be Affected

  • Patients who need cardiac support using the HeartMate 3 LVAS System.
  • Health care providers who plan to use the HeartMate 3 LVAS System for their patients.
 

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