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ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX P...

FDA Device Recall #Z-0008-2019 — Class I — July 31, 2018

Recall Summary

Recall Number Z-0008-2019
Classification Class I — Serious risk
Date Initiated July 31, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Endologix
Location Irvine, CA
Product Type Devices
Quantity 56503

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

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 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

Lot / Code Information

All lots distributed from 03/2011 to present.

Other Recalls from Endologix

Recall # Classification Product Date
Z-0006-2019 Class I ENDOLOGIX AFX Endovascular AAA System, Stent Gr... Jul 31, 2018
Z-0007-2019 Class I ENDOLOGIX AFX2 Bifurcated Endograft System, Ste... Jul 31, 2018
Z-0009-2019 Class I ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endo... Jul 31, 2018
Z-1049-2017 Class II AFX2 Endovascular AAA System Item No. I... Jan 4, 2017
Z-1048-2017 Class II AFX Endovascular AAA System Item Number Ite... Jan 4, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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