# FDA recall Z-2263-2020

> **Endologix, Inc.** · Class I · device recall initiated 2020-05-06.

## 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

## Reason for recall

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.

## Distribution

Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Taiwan, Thailand, Canada, Austria, Belgium, Cyprus, Czech Republic, Germany, Hungary, Ireland, Italy, Switzerland, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, and United Kingdom

## Key facts

- **Recall number:** Z-2263-2020
- **Recalling firm:** Endologix, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-06
- **Report date:** 2020-06-17
- **Termination date:** 2024-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Rosa, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2263-2020

## Citation

> AI Analytics. FDA recall Z-2263-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-2263-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*