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Abbott recalls LVAS after two deaths, 70 injuries

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.

U.S. Food and Drug Administration

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