Thoratec HeartMate II Artificial Heart Lawsuits
October 23rd, 2008 • Filed Under: Lawsuits • One Comment
On October 15, 2008, Thoratec Corporation issued a warning for the HeartMate II Left Ventricular Assist System after it was discovered that the percutaneous lead connecting the blood pump with the System Controller could wear or fatigue, potentially causing interruption of pump function.
STATUS OF THORATEC HEARTMATE LAWSUITS: Potential cases are being reviewed and investigated by Thoratec HeartMate lawyers on behalf of individuals throughout the United States who have experienced problems with their artificial heart.
>>SUBMIT A CASE TO A THORATEC HEARTMATE LAWYER<<
MANUFACTURER: Thoratec Corporation
OVERVIEW: The Thoratec HeartMate II Left Ventricular Assist System (HM II LVAS) is a blood pump that is implanted in people with a diseased or damaged heart to help pump blood throughout the body. The mechanical heart is a small device that is designed for children, women and small men.
The HeartMate II LVAS was first used in clinical trials beginning in November 2003. At least 1,972 people have received the implantable artificial heart.
HEART MATE 2 RECALL NOTICE: An Urgent Device Correction Notice was issued for HeartMate II LVAS pumps with catalogue numbers 1355 to 102139 on October 24, 2008.
The percutaneous lead that connects the blood pump with the System Controller has been found to wear or fatigue over time, potentially leading to an interruption of pump function. This could result in the need for surgery to replace the artificial heart or cause potentially fatal injury.
Thoratec has received reports of 27 individuals who had their percutaneous lead wear or fatigue, requiring pump replacement. Five of these cases resulted in death.
According to estimates, the risk of lead damage increases the longer the blood pump is in place:
- 1.3% fail at 12 months
- 6.5% fail at 24 months
- 11.4% fail at 36 months
Doctors and hospitals have been notified about the risk of HeartMate blood pump problems with the lead, and have been advised to immediately replace the artificial heart if lead damage is confirmed.
Pingback by Thoratec HeartMate II Blood Pump Warning: Lead May Fail : AboutLawsuits.com on 27 October 2008:
[...] Corporation has warned that their HeartMate II blood pump may fail due to a defective lead that connects the heart pump with the System Controller. The lead [...]