Endologix
Endologix appears in FDA public data with 14 recalls — including 6 Class I (most serious) —, 5 510(k) clearances, 14 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2263-2020, Class I) was initiated on May 6, 2020. Its most recent 510(k) clearance was granted on February 9, 2012.
Summary
- Total Recalls
- 14 (6 Class I)
- 510(k) Clearances
- 5
- Inspections
- 14
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2263-2020 | Class I | Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, T | May 6, 2020 |
| Z-0006-2019 | Class I | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22 | July 31, 2018 |
| Z-0007-2019 | Class I | ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: | July 31, 2018 |
| Z-0008-2019 | Class I | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Prox | July 31, 2018 |
| Z-0009-2019 | Class I | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model | July 31, 2018 |
| Z-1048-2017 | Class II | AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C7 | January 4, 2017 |
| Z-1049-2017 | Class II | AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-0 | January 4, 2017 |
| Z-1047-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System i | December 27, 2016 |
| Z-1038-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for en | December 27, 2016 |
| Z-1039-2017 | Class II | AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent | December 27, 2016 |
| Z-1037-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent G | December 27, 2016 |
| Z-1035-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIA | December 27, 2016 |
| Z-1054-2017 | Class II | AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent G | December 27, 2016 |
| Z-1436-2013 | Class I | Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 10 | May 13, 2013 |