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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80812

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 31, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Endologix

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40, BA22-40/I13-40, BA22-110/I20-30, BA22-90/I20-30, BA22-70/I20-30, BA22-50/I20-30, BA22-110/I16-30, BA22-90/I16-30, BA22-70/I16-30, BA22-50/I16-30, BA22-100/I20-55, BA22-80/I20-55, BA22-100/I16-55, BA22-80/I16-55, BA25-120/I20-40, BA25-100/I20-40, BA25-80/I20-40, BA25-60/I20-40, BA25-40/I20-40, BA25-120/I16-40, BA25-100/I16-40, BA25-80/I16-40, BA25-60/I16-40, BA25-40/I16-40, BA25-120/I13-40, BA25-100/I13-40, BA25-80/I13-40, BA25-60/I13-40, BA25-40/I13-40, BA25-110/I20-30, BA25-90/I20-30, BA25-70/I20-30, BA25-50/I20-30, BA25-110/I16-30, BA25-90/I16-30, BA25-70/I16-30, BA25-50/I16-30, BA25-100/I20-55, BA25-80/I20-55, BA25-100/I16-55, BA25-80/I16-55, BA28-120/I20-40, BA28-100/I20-40, BA28-80/I20-40, BA28-60/I20-40, BA28-40/I20-40, BA28-120/I16-40, BA28-100/I16-40, BA28-80/I16-40, BA28-60/I16-40, BA28-40/I16-40, BA28-120/I13-40, BA28-100/I13-40, BA28-80/I13-40, BA28-60/I13-40, BA28-40/I13-40, BA28-110/I20-30, BA28-90/I20-30, BA28-70/I20-30, BA28-50/I20-30, BA28-110/I16-30, BA28-90/I16-30, BA28-70/I16-30, BA28-50/I16-30, BA28-100/I20-55, BA28-80/I20-55, BA28-100/I16-55, BA28-80/I16-55

Z-0006-2019
Recall number
Z-0006-2019
Initiated
July 31, 2018
Classification
Class I
Status
Terminated
Recalling firm
Endologix
Quantity
45304

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

device · product 2 of 4

ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-40/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-40/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-40/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-40/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-40/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-40/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-40/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-40/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55

Z-0007-2019
Recall number
Z-0007-2019
Initiated
July 31, 2018
Classification
Class I
Status
Terminated
Recalling firm
Endologix
Quantity
13178

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

device · product 3 of 4

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

Z-0008-2019
Recall number
Z-0008-2019
Initiated
July 31, 2018
Classification
Class I
Status
Terminated
Recalling firm
Endologix
Quantity
56503

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

device · product 4 of 4

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

Z-0009-2019
Recall number
Z-0009-2019
Initiated
July 31, 2018
Classification
Class I
Status
Terminated
Recalling firm
Endologix
Quantity
17789

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Field note

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