Thoratec HeartMate II LVAS Recall Issued After Bleeding Problems, Death

Problems with the Thoratec HeartMate II Left Ventricular Assist System, which may have caused the death of at least one patient, has led to a recall for all models. 

The Thoratec Heartmate II recall was announced by the FDA and the manufacturer on March 19, following an analysis of reports of incidents over the last two years. Thoratec previously initiated a medical device correction notification last month.

According to adverse event reports, the sealed outflow graft bend relief may become disconnected from the Heartmate II Left Ventricular Assist System (HM II LVAS). There have been 29 such reports that have occurred out of the 3,200 units sold.

The disconnected outflow graft can cause bleeding, low pump flow, hemolysis, fluctuations in pump flow, speed and power as well as worsening symptoms of heart failure.

All but five of the reported incidents were discovered in x-ray images or during surgical procedures and not linked to any problems. However, in five cases surgical intervention was required. In one incident a patient died of multi-organ failure, but it is unclear whether the patient’s death was caused by a defective HM II LVAS.

The recall affects all serial numbers of the HeartMate II Left Ventricular Assist System with catalog numbers 104692, 103393, 104911, and 104912. The devices were distributed to 226 hospitals worldwide. The catalog number is located on the label of the package. For patients who may already have the implants installed, the catalog number is located on the adhesive label that came with the device for inclusion in the patient’s medical records.

Thoratec has released new instructions on how to secure the bend relief to the outflow graft and advises doctors to be aware of the potential symptoms of a problem. Doctors and patients with questions have been advised to call the company at (800) 528-2577 in the U.S. or (925) 847-8600 from outside of the U.S.

Adverse events associated liked to problems with the Thoratec HeartMate II should be reported to the company and to the FDA’s adverse event reporting program, MedWatch.