Heartmate II Recall :
On October 26, 2008 Thoratec Corp. issued a recall of its “HeartMate II LVAS” mechanical heart pumps after receiving reports that 5 people have died while using the device and at least 27 reports of need for replacement. According tho the FDA recall notice , Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage.

Pumps Affected:
The recall affects devices with catalog numbers 1355 and 102139, which have been distributed to 153 hospitals and distributors throughout the United States and other countries since the beginning of clinical studies in November 2003.

Why Are The Pumps Being Recalled?
Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Additional Information:
Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

HeartMate II News Archive::

If you or someone you love were injured as a result of the defective Thoratec HeartMate II LVAS implantable heart pump you may be entitled to compensation. Contact the HeartMate II Attorneys of Ennis & Ennis, P.A. today for a free case evaluation. Our experience lawyers are standing by to answer any questions you may have regarding the HeartMate II LVAS heart pump recall, and your potential Thoratec HeartMate II LVAS heart pump lawsuit.