medical Class I Updated 2020-06-17

Endologix, Inc. recalls Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I,

Recalled Product

Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J

Hazard / Issue

A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lot and Serial Numbers not yet implanted
View official government recall

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