CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
AFX Endovascular AAA System, Endoleak Type IIIA recalled by Endologix
Endologix is recalling AFX Endovascular AAA System, Endoleak Type IIIA. The recall was initiated on 27 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1035-2017
- FDA event ID
- 76075
- Recalling firm
- Endologix, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2016
- FDA classified
- 18 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 27 Dec 2016 | Recall initiated by company | |
| 18 Jan 2017 | Classified by FDA | +22 days |
| 25 Jan 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AFX Endovascular AAA System, Endoleak Type IIIA
Where it was distributed
Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
The correction is not lot specific. It applies to AFX procedures conducted after June 2013
Where was it sold?
Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Endologix
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Ovation iX Abdominal Stent Graft Systems recalled by Endologix | Endologix | Packaging Defects | Nationwide |
| Device | CLASS I | AFX/AFX2, Limb (Iliac) Extension Endograft recalled by Endologix | Endologix | Packaging Defects | 52 states |
| Device | CLASS I | AFX2 Bifurcated Endograft System, Stent Graft System recalled | Endologix | Packaging Defects | 52 states |
| Device | CLASS I | AFX Endovascular AAA System, Stent Graft System recalled by Endologix | Endologix | Packaging Defects | 52 states |
| Device | CLASS I | AFX/AFX2, Proximal (Aortic) Extension Endograft recalled by Endologix | Endologix | Packaging Defects | 52 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |