CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
AFX Endovascular AAA System, Endoleak Type IIIB recalled by Endologix
Endologix is recalling AFX Endovascular AAA System, Endoleak Type IIIB. 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-1038-2017
- FDA event ID
- 76110
- 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 updated the Instructions for Use (IFU) and implemented modifications to 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 IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Where it was distributed
US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Questions about this recall
Is AFX Endovascular AAA System, Endoleak Type IIIB recalled?
Yes. Endologix recalled AFX Endovascular AAA System, Endoleak Type IIIB on 27 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1038-2017.
Why was it recalled?
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Which lots are affected?
The correction is not lot specific. It applies to AFX procedures conducted after July 2015
Where was it sold?
US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, 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 21 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
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|---|---|---|---|---|---|
| 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 | Sterility | 52 states |
| Device | CLASS I | AFX2 Bifurcated Endograft System, Stent Graft System recalled | Endologix | Sterility | 52 states |
| Device | CLASS I | AFX Endovascular AAA System, Stent Graft System recalled by Endologix | Endologix | Sterility | 52 states |
| Device | CLASS I | AFX/AFX2, Proximal (Aortic) Extension Endograft recalled by Endologix | Endologix | Sterility | 52 states |
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| 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 |