Abbott HeartMate Gets Third Class I Recall This Year

For the third time this year, the FDA has deemed an Abbott recall of its HeartMate 3 Left Ventricular Assist System (LVAS) as Class I, the most serious type of recall, following 81 reported incidents, 70 injuries and two deaths related to the issue.

Abbott is recalling the HeartMate 3 LVAS after reviews of complaints 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,” the FDA said.

The company recalled the device in January because it could unexpectedly stop and start and in February because of the potential for extrinsic outflow graft obstruction.

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