Abbott/Thoratec Heartmate LVAS Deaths Result in Class I Recall

The Abbott/Thoratec recall of HeartMate II and HeartMate 3 left ventricular assist system (LVAS) has been deemed Class I, the most serious type of recall, by the FDA.

The HeartMate II and HeartMate 3 LVAS help the heart pump blood and can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant is not an option.

The devices have been recalled due to extrinsic outflow graft obstruction, which occurs when biological material builds up — over about two years or more — between the HeartMate outflow graft and the outflow graft bend relief or additional components added during surgery.

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