Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS) Recalled because the Outflow Graft May Kink or Deform causing Serious Adverse Events

The FDA informs Cardiology, Risk Manager and Transplant healthcare personnel that Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS) is recalled because the outflow graft may kink or deform, resulting in reduction of blood flow and may cause serious adverse health consequences, including death.

Background of HeartMate II Left Ventricular Assist System (LVAS)

HeartMate II Left Ventricular Assist System (LVAS), by Thoratec Corporation, is a left ventricular assist device (LVAD) system that helps the heart’s left ventricle deliver blood to the rest of the body. Its indication is for use as a bridge to transplantation in heart transplant candidates at risk of imminent death from non-reversible left ventricular failure.

It use is intended to be both inside and outside the hospital or during transportation of ventricular assist device patients.

FDA Alert on HeartMate II Left Ventricular Assist System (LVAS)

FDA’s reason for the recall is that HeartMate II Left Ventricular Assist System (LVAS), due to detachment of the bend relief from its intended position around the proximal outflow graft, may allow the graft to kink or deform, resulting in reduction of blood flow and causing serious adverse events.

The model numbers that are affected by this recall are: 103393, 103695, 104692, 104911 and 104912.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

FDA Recommendation on HeartMate II Left Ventricular Assist System (LVAS)

“The device labeling has been revised to provide instructions on how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant and new caution statement regarding the bend relief connection are included.  Clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft.”

Contacting the FDA to report cases with HeartMate II Left Ventricular Assist System (LVAS)

In case of detection of adverse events or side effects related to the use of HeartMate II Left Ventricular Assist System (LVAS), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.