RegWardenFDA facility compliance records
Facility

Endologix LLC

10 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2013: 1 recalls; 2016: 6 recalls, 1 inspections; 2017: 1 recalls; 2018: 1 recalls; 2020: 1 recalls, 1 inspections; 2021: 1 inspections1’13’14’157’161’171’18’192’201’21’22’23’24’25’26
  • Recalls (10)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

  • Class ITerminated2020-05-06
    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…
  • Class ITerminated2018-07-31
    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 rel…
  • Class IITerminated2017-01-04
    Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
  • Class IITerminated2016-12-27
    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
  • Class IITerminated2016-12-27
    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
  • Class IITerminated2016-12-27
    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
  • Class IITerminated2016-12-27
    Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
  • Class IITerminated2016-12-27
    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
  • Class IITerminated2016-12-27
    Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
  • Class ITerminated2013-05-13
    Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.

FDA inspections (3)

  • VAI2021-08-03
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2020-02-20
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2016-05-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Endologix LLC (FEI 3011063223) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011063223-endologix-llc/

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