FDA designates recall of abdominal stent graft system as class 1
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The FDA has designated Endologix’ recall of an abdominal stent graft system as a class 1 recall, the most serious kind.
The recall affects 5,403 devices (Ovation iX Abdominal Stent Graft Systems) manufactured and distributed in the U.S. since 2015, according to a safety alert from the agency.
The device, which is used to treat patients with abdominal aortic or aortoiliac aneurysms, was recalled due to potential liquid polymer leaks during implantation. Endologix previously distributed a safety update in August 2018, alerting customers of polymer leaks due to incorrect device use.
This recall, which was issued on May 6, 2020, provides clarification that most of the leaks are due to material weakness resulting from the manufacturing process, according to the alert. The weak material may open or gap during use, which can result in a liquid polymer leak as it is filled. A lack of liquid polymer may lead to continuous blood flow into the aneurysm, which would require additional procedures to seal it off. The liquid polymer may also leak into the body, causing severe allergic reactions, necrosis, unstable BP, cardiac arrest, organ failure, death and central nervous system problems.
Endologix distributed a notice May 6, 2020, alerting customers to be aware of the notice distributed in August 2018, to consider the risk for polymer leaks and to consider alternative treatment options when making decisions for patients, as well as to report any adverse reactions or quality problems to the agency.
The company also issued a press release on June 15, 2020 on the updated lifetime rate of leaks and complications and that this device will be replaced by another graft system (ALTO Abdominal Stent Graft System) by October 31, 2020, according to the alert. In addition, the device’s labeling will include a new warning of the potential polymer leak.
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