Endologix: Medical Device Recall in 2018 - (Recall #: Z-0008-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100; Suprarenal Model #/REF: A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-28/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20; AFX Vela, Infrarenal Model #/REF: A22-22/C55V, A22-22/C75V, A22-22/C95V, A25-25/C55V, A25-25/C75V, A25-25/C95V, A28-28/C55V, A28-28/C75V, A28-28/C95V, A31-31/C80V, A31-31/C100V, A34-34/C80V, A34-34/C100V; Suprarenal Model #/REF: A22-22/C55-O20V, A22-22/C75-O20V, A22-22/C95-O20V, A25-25/C55-O20V, A25-25/C75-O20V, A25-25/C95-O20V, A28-28/C55-O20V, A28-28/C75-O20V, A28-28/C95-O20V, A31-31/C80-O20V, A31-31/C100-O20V, A34-34/C80-O20V, A34-34/C100-O20V

Product Classification:

Class I

Date Initiated: July 31, 2018

Date Posted: October 10, 2018

Recall Number: Z-0008-2019

Event ID: 80812

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.

Status: Terminated

Product Quantity: 56503

Code Information:

All lots distributed from 03/2011 to present.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated