Drug recall
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts…
FDA recall event 76106 · Class II · Endologix
Key facts
| Event ID | 76106 |
|---|---|
| Recall numbers | Z-1054-2017 |
| Recalling firm | Endologix |
| Product type | Devices |
| Products | AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). |
| Initiation date | Dec 27, 2016 |
| Report date | Jan 25, 2017 |
| Termination date | Apr 28, 2017 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3011063223 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: