The Food and Drug Administration has announced a class 1 recall of the TigerPaw System II, a medical device used during heart surgery that is manufactured by Maquet Medical Systems. According to the FDA recall announcement, the TigerPaw II may cause tissue tearing or bleeding when used during heart surgery. The FDA has received at list 51 reports of adverse events linked to the TigerPaw II, including at least one death.
The Tiger Paw System II is a type of surgical staple used to close tissue in the left atrial appendage (LAA) of the heart during surgery. However, Maquet has received reports that the device is actually tearing the LAA and causing it to bleed, putting patients at risk of serious and potentially fatal health consequences.
The recall notice announced by the FDA involves 4,154 TigerPaw II devices that were distributed by Maquet between April 2013 and March 2015. Hospitals and other medical facilities who have purchased TigerPaw II devices will receive a letter from Maquet informing them: “Urgent Medical Device Recall (Removal) Immediate Action Required”. These facilities have been instructed to inventory and quarantine any TigerPaw II devices still at their facilities in order to make sure that they are not used.
The FDA has cited Maquet for several violations at its manufacturing facilities in recent years. Maquet recalled 45 medical devices between 2009 and 2014, including five Class 1 recalls, the most serious type ordered by the FDA. In February 2015, the FDA and Maquet reached a $6 million settlement to end a federal lawsuit filed in New Hampshire over poor quality control at three of the company’s subsidiaries.
Product Liability Lawsuits Filed Over Problems Caused By Medical Device Defects
The FDA and other regulatory agencies monitor the safety and effectiveness of surgical devices and other medical products to ensure that they are safe and effective. But despite these efforts, thousands of patients are seriously injured each year due to complications caused by improperly manufactured devices or other medical products.
Patients who have been injured by problems with a medical device or other defective products may wish to speak with an attorney about filing a product liability lawsuit against the manufacturers of these devices. The lawyers at Heygood, Orr & Pearson have the trial experience, knowledge, and legal expertise to pursue a product liability or personal injury claim against any company whose defective products cause serious injury or death.
At Heygood, Orr & Pearson, we believe that when companies who manufacture medical devices fail to properly ensure that their products meet minimum health and safety standards, they should be held accountable for the injuries and illnesses caused by their products. We believe that all patients deserve access to qualified legal counsel to represent their interests and ensure that their rights our protected.
The lawyers at Heygood, Orr & Pearson have resolved hundreds of claims involving defective medical products, dangerous drugs, and medical malpractice on the part of doctors or hospitals. Our attorneys have secured verdicts and settlements for our clients totaling more than $200 million. We not only have the financial resources to take a case to trial, but the legal expertise to ensure that your legal rights are protected in a court of law.
For a free legal consultation about your case and to find out more about filing a lawsuit, contact the law office of Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form, and one of our staff members will be in touch with you as soon as possible to discuss your situation.