Endologix Ovation iX Abdominal Stent Graft Systems Recalled for Polymer Leak Risk
Endologix is recalling Ovation iX Abdominal Stent Graft Systems because a material weakness may cause polymer leaks during implantation, potentially leading to clinical events.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the potential for systemic and aneurysm-related clinical events constitutes a significant injury risk.
Plain-English summary
Endologix, Inc. is recalling 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). The recall involves 9,156 units that have not yet been implanted. The products were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Canada, Germany, Japan, and the United Kingdom.
The recall is due to a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. This defect may result in polymer leaks during the implantation of the abdominal stent graft system. Clinical events related to these leaks may be systemic and/or aneurysm related.
Healthcare providers and patients should contact Endologix, Inc. for further instructions regarding the recall and potential replacement or return of the affected devices.
The recalled product
- 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
- Manufacturer
- Endologix, Inc.
- Affected units
- 9,156
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot and Serial Numbers not yet implanted
Distribution
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