Thoratec Recalls HeartMate 3 and LVAS Implant Kit

Abbott’s Thoratec unit has recalled (Class 1) its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak. A recall notice says there is risk of a “leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.”

The company has sent customers an urgent medical device correction notification indicating that affected products are not being removed from the field. It recommended that if a blood leak or air entrainment is suspected or observed, customers should follow standard surgical processes and the existing “information for use,” according to the notice. It also says residual air must be completely evacuated from the device blood chamber before initiating the left ventricle support device. “Ensure that bleeding is assessed and ensure proper management of hemostasis before closing all wounds,” it adds.