The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Endologix Ovation iX Abdominal Stent Graft System because of the risk of severe injury or death. According to an FDA alert, the recall involves about 5,403 devices that were distributed in the United States since August 2015. The recalled products have a manufacturing defect that has been linked to five deaths.
The stents involved in this recall are used to repair abdominal aortic aneurysms, a condition that occurs when the body’s largest blood vessel known as the aorta develops a weak spot that bulges onward until it suddenly bursts open. Unlike traditional stent grafts, the Ovation iX contains a liquid polymer. However, due to a manufacturing error, this liquid polymer can potentially leak out of the graft and cause severe, life-threatening complications for patients.
In an update issued on June 15th, Endologix said 112 patients had suffered adverse health effects due to this polymer leakage issue including five patients who died from complications. Some of the most serious adverse effects include low blood pressure, multi-organ failure, cardiac arrest, hypersensitivity reactions and tissue necrosis. The company first reported this issue back in 2018. However, at the time, the medical device manufacturer blamed the problem on the user.
Now, Endologix says the leaks are because of “material weakness next to the polymer channel.” Between the time it was first reported and the recent recall, 65 additional patients have been affected because of the polymer leaks. Endologix is now asking doctors to transition to another stent graft called Alto, which has been redesigned to repair problems with material weaknesses.
Product Liability Issues
Medical device manufacturers have a responsibility to make products that are safe for consumers. There is no question that patients suffer more stress and trauma when medical devices malfunction because often they are placed inside the patient’s body and additional surgeries or medical procedures are almost always required to remedy the situation.
If you have received these stents and have suffered from complications as a result of the polymer leakage, you may be able to file a product defect lawsuit against the manufacturer seeking compensation for losses such as medical expenses, lost income, hospitalization, unnecessary surgeries, rehabilitation costs, pain and suffering and emotional distress. An experienced product defect lawyer can help you better understand your legal rights and options.