# FDA recall Z-0009-2019

> **Endologix** · Class I · device recall initiated 2018-07-31.

## Product

ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: 									  I16-16/C55,		  I16-16/C55F,		  I16-16/C88,		  I20-13/C70F,		  I20-13/C88F,		  I16-16/C55,		  I16-16/C55F,		  I16-16/C88,		  I20-13/C70F,		  I20-13/C88F;		    AFX Stand Alone  I16-16/C55 SA,															  I16-16/C55F SA,															  I16-16/C88 SA,															  I20-13/C70F SA,															  I20-13/C88F SA,															  I20-20/C55 SA,					  I20-20/C55F SA,					  IS20-25/C55 SA,					  IF20-25/C65 SA,					  IS20-25/C65 SA

## Reason for recall

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device.  This is a follow-up notification to the one that was sent out in December 2016.  The updates are related to the observation of Type III endoleaks.

## Distribution

U.S.:  PA, VA, CA, AZ, IN, GA, FL, IL, OK, MN, OH, KY, MS, NC, MI, AL, CT, LA, SC, TN, NY, WI, MD, WV, AR, NV, NJ, TX, CO, NE, NM, MA, IA, AK, OR, ME, SD, MO, MT, KS, DE, WA, UT, NH, ND, DC, RI, HI, WY, ID, VT, PR;    Foreign (OUS):  Canada, Argentina, Australia, Brazil, CHILE , Hong Kong, Japan, South Korea, Philippines, Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom

## Key facts

- **Recall number:** Z-0009-2019
- **Recalling firm:** Endologix
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-31
- **Report date:** 2018-10-10
- **Termination date:** 2024-04-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2019

## Citation

> AI Analytics. FDA recall Z-0009-2019. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0009-2019. Source: US FDA. Licensed CC0.

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