The FDA has granted the HeartMate II a class I recall, which is its most serious status; it indicates that exposure to the device has a reasonable chance of leading to serious side effects or death.
Port Washigton, NY (PRWEB) April 07, 2012
Parker Waichman LLP, a national law firm representing victims of defective medical devices, is alerting the public about Thoratec’s HeartMate II Left Ventricular Assist System (LVAS), a heart pump device recently recalled by the FDA. According to Parker Waichman LLP, the heart pump device is improperly detaching, which can result in serious injury or death.
On March 19th, Thoratec revealed that it had received 29 reports concerning the same component of the device. In response, the company had to issue a “medical device correction notification” addressing the problem. According to Reuters, there were five cases where patients required additional surgery, with one case resulting in death. [.reuters.com/article/2012/04/04/thoratec-idUSL3E8F46US20120404]
The FDA has granted the HeartMate II a class I recall, which is its most serious status; it indicates that exposure to the device has a reasonable chance of leading to serious side effects or death. However, instead of removing the device from the market, the agency has updated its instructions for surgeons, which includes a “new caution statement regarding the bend relief connection”. Specifically, the update affects model numbers 103393, 103695, 104692, 104911 and 104912.
Thoratec Heart Mate II, a system that can cost as much as $100,000, is supposed to help the heart pump blood to the rest of the body in patients who have an impaired left ventricle. It is approved for patients who are on the waiting list for a heart transplant or who do not qualify for one. The device incorporates a system of tubes, referred to as grafts, which are supposed to help deliver oxygenated blood from the left side of the heart to the major artery, which then sends the blood to the rest of the body. A vital component known as the bend relief shields the tubes to prevent any unwanted bending. However, it appears that the bend relief has been detaching, causing the kinks in the grafts and impeding blood flow to the rest of the body. The FDA is also concerned that “the metal end of the bend relief may be sharp and cause erosion and cutting of the outflow graft.” http://publichealthwatchdog.com/?p=6786
Parker Waichman LLP has been closely following Thoratec heart pumps for several years, particularly after the company’s last recall of a prior version of this device in 2008.
Parker Waichman LLP offers free legal consultation to those who have been exposed to Thoratec HeartMate II. If you or a loved one experienced serious complications associated with the HeartMate II, please contact their office by visiting the firm’s Thoratec LVAS Heart Pump Recall page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Thoratec HeartMate II lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP
Herbert Waichman, Partner