Advice on for Patients with the Thoratec Heartmate II LVAS Medical Device

What is the HeartMate II?

The HeartMate II Left Ventricular Assist System (LVAS) is a left ventricular assist device (LVAD) that utilizes a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricle of the heart and ejects the blood into the aortic root.

HeartMate II Left Ventricular Assist Systems Recalled by FDA

The manufacturers of HeartMate II Left Ventricular Assist Systems, Thoratec Corporation, have initiated a worldwide medical device correction. This includes all serial numbers of the Heartmate II Left Ventrical Assist Systems (HM II LVAS) with catalogue numbers 1355 or 102139.

These Heartmate II systems have been distributed since the beginning of November 2003 when clinical studies were started. There have been 27 confirmed reports that wear and use to the percutaneous has lead to a necessary pump replacement. These confirmed reports have occurred over five years of clinical experience and include 1,972 implants. To date, all patients who have undergone a replacement of the HeartMate II pump survived the operation and lived at least 30 days beyond the operation. There have been five cases in which pump replacement was not feasible and those patients have died.

Click to learn more about this FDA recall and your legal rights.

Find a HeartMate Lawyer/Attorney

If you or someone you love was hurt by the HeartMate II Left Ventricular Assist System, submit the “Contact Us” form to receive information from defective product attorneys and have your case evaluated today!