The US Food and Drug Administration (FDA) has tagged a recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) as Class I, the most serious designation for a medical device.

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.

As the recall is a product correction, Abbott noted that an unused product is not to be returned as “product is not being removed from the field”, in a letter to customers.

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The company advised that standard surgical processes and the existing instructions for use are to be followed if a blood leak or air entrainment is suspected or observed. This includes the removal of residual air before starting LVAD support, proper haemostasis management, and availability of a backup system for use in case of emergency.

Abbott also advised strategies for resolving air leaks or surgical bleeding – “adjusting the pump position, waiting for the natural tendency of blood to coagulate or upon reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff, the pump, or both”.

Abbott also had a recall of its Proclaim neurostimulation systems and Infinity IPGs tagged as Class I by the agency in September 2023.