Endologix recalls

Endologix has 13 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 17 Jun 2020. The most frequent reason is packaging defects.

Total recalls13since 2013

Last 12 months0reported

Class I646% of total

Ongoing0latest 17 Jun 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 6 46%Class II 7 54%Class III 0 0%

Why endologix is recalled

Product types

Heart & Vascular Devices1292%
Other Medical Devices18%

By year

202018%
2018431%
2017754%
201318%

All endologix recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2020Device	CLASS I	Ovation iX Abdominal Stent Graft Systems recalled by Endologix	Endologix	Packaging Defects	Nationwide
10 Oct 2018Device	CLASS I	AFX/AFX2, Limb (Iliac) Extension Endograft recalled by Endologix	Endologix	Sterility	52 states
10 Oct 2018Device	CLASS I	AFX2 Bifurcated Endograft System, Stent Graft System recalled	Endologix	Sterility	52 states
10 Oct 2018Device	CLASS I	AFX Endovascular AAA System, Stent Graft System recalled by Endologix	Endologix	Sterility	52 states
10 Oct 2018Device	CLASS I	AFX/AFX2, Proximal (Aortic) Extension Endograft recalled by Endologix	Endologix	Sterility	52 states
25 Jan 2017Device	CLASS II	AFX Endovascular AAA System recalled by Endologix	Endologix	Packaging Defects	Nationwide
25 Jan 2017Device	CLASS II	AFX Endovascular AAA System, Endoleak Type IIIB recalled by Endologix	Endologix	Packaging Defects	CA
25 Jan 2017Device	CLASS II	AFX Endovascular AAA System, Endoleak Type IIIA recalled by Endologix	Endologix	Packaging Defects	CA
25 Jan 2017Device	CLASS II	AFX Endovascular AAA System, Endoleak Type IIIA recalled by Endologix	Endologix	Packaging Defects	CA
25 Jan 2017Device	CLASS II	AFX2 Endovascular AAA System recalled by Endologix	Endologix	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.