UNITED STATES – June 18, 2020 – According to a news report published on healio.com, the U. S. Food and Drug Administration has placed a Class 1 Recall on abdominal stent graft system manufactured Endologix on June 16, 2020. A Class 1 Recall is the most severe type of recall, and this type of recall means the product is likely to cause injuries or death. This recall
The recall affects 5,403 Ovation iX Abdominal Stent Graft System devices that were fabricated and sold in the United States since 2015, according to the FDA’s safety alert. The medical devices are used in the treatment of patients who have aortoiliac aneurysms or abdominal aortic aneurysms. The abdominal stent graft system was recalled because of the unsafe liquid polymer leaks that may occur as the surgical device is surgically implanted.
Recall Information: Endologix Ovation iX Abdominal Stent Graft System
- All Lot Numbers are being recalled.
- Model Numbers: TV-AB2080-J; TV-AB2380-J; TV-AB2680-J; TV-AB2980-J; and TV-AB3480-J
- Recalled Device Manufacturing Date: 2015 to Present
- Recalled Device Distribution Dates: August 31, 2015, to Present
- Number of Recalled Devices Implanted in the U.S.: 5,403
According to the news article, Endologix had previously issued a product safety update back in August 2018. This alert warned patients on potential polymer leaks, which may occur due to incorrect device applications.
This recall was initiated on May 6, 2020; however, the updated recall information, published on June 15, 2020, clarifies that a majority of the liquid polymer leaks are due to the weakness of the material used during the manufacturing process. The defective material can open or create a gap when being implanted or used, and this can cause the liquid polymer to leak as the device is being filled. If the liquid polymer leaks, the polymer could cause continuous aneurysm blood flow requiring additional surgical procedures to close off the leak. The device’s liquid polymer could leak into the patient’s body, causing severe injuries and death. The reported side effects of the leaking device include:
- severe allergic reactions,
- unstable blood pressure,
- organ failure,
- cardiac arrest,
- central nervous system complications,
- and/or death.
Endologix distributed a press release on June 15, 2020, which updated the lifetime rates of the polymer leaks and the potential of serious complications. The press release also stated this surgical device would be replaced by another graft system. The replacement device announced in the press release is called the ALTO Abdominal Stent Graft System.
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