Thoratec HeartMate II Recall Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A. are investigating potential Thoratec HeartMate II lawsuits throughout the United States. The percutaneous lead that connects the Thoratec Heart Mate 2 Left Ventrical Assist System with the System Controller has been found to wear of fatigue over time. This could interrupt pump function, resulting in surgery to replace the heart blood pump or potentially result in death.
>>FDA NOTICE OF RECALL: Thoratec HeartMate II VAS
On October 24, 2008, Thoratec corporation issued a mechanical heart recall for their HeartMate II Left Ventricular Assist Systems (HM II LVAS), with catalogue numbers 1355 to 102139. Approximately 1,972 of these artificial hearts have been implanted since clinical trials began in November 2003 and estimates suggest that a large number of people could experience damage to the lead.
The company has already confirmed at least 27 cases of wear and fatigue to the percutaneous lead required surgery to replace the blood pump. Five of these reports involved people who were unable to successfully have the pump replaced and they have died.
The Thoratec HeartMate II Left Ventricular Assist System is a small blood pump that was approved in April 2008. It has been used in children, women and small men to help pump blood throughout the body while they await a heart transplant.
According to the HeartMate II recall notice posted on the FDA Website:
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.
THORATEC HEARTMATE LAWYERS
If you, a friend or family member have a Thoratec HeartMate 2 Left Ventricular Assist System with catalogue number 1355 to 102139, your device is impacted by this warning notice. Contact your physician for concerns about what this may mean for your health, and seek immediate medical attention as soon as possible if you suspect damage to the percutaneous lead.
The HeartMate pump lawyers at Saiontz & Kirk, P.A. are investigating potential lawsuits for individuals who have required medical treatment as a result of potential damage to the percutaneous lead. To review your legal rights, request a free consultation and claim evaluation.
4 Comments • Add Your Comments
Alexis says:
I have serial number PSD 1509A and ref 28536 i do not know my catalog number could someone please inform me of which catalog number that i have because i called thoratec and spoke with armando in their technical support department of the company and he was very reluctant about giving me that information.
Posted on January 21, 2009 at 7:40 pm
Kevin says:
The discharge connection between the pump outlet elbow and the flexible hose that extends to the aorta is starting to loosen. This was determined by a contrast CT scan on 3/15/2012. I feel that is a dangerous situation with a catastrophic failure possible. Should the connector sleeve continue to move there would be significant immediate blood lose that could result in death.
This pump design is not the original design. It was changed for ease of surgical installation with a coupling that was easily connected and disconnected. There appears to be a major problem.
Posted on March 18, 2012 at 1:28 am
Rebekah says:
My husband was implanted in July 2012 and in September 2013 My husband began to urinate blood as his heart mate 2 began chewing up his red blood cells. My husbands LVAD burned up inside of his body as it continued to fill with blood clots. His device was disconnected and left inside of his body. The doctors feared removing it for the 100% chance of throwing a clot to the brain. Leaving it in he has a 50-50 chance. He has had mini strokes and seizures since. Has anyone else had their pump burn up inside of their body?
Posted on February 28, 2014 at 4:22 pm
richard says:
I HAD TWO HARTMATE PUT IN, THE FIRST GAVE ME GI BLEEDING,INHOSPITAL 3 DIFFERNT TIMES.THE 1ST.ONE LASTED 11 MONTHS THE 1ST,AND 2ND CLOG WITH BLOODCLOTS,THE 2ND PUMP ONLY LASTED ONE MONTH.I NOW HAVE HART WARE IN ME ONE MONTH IN. MY FIRST PUMP WAS JUNE 2013 2ND ON MAY 2014 THE 3RD JUNE2014 I HAD 3 PUMPS PUT IN .
Posted on September 1, 2014 at 1:18 pm