Endologix
Complete recall history across all FDA and CPSC categories — 12 total recalls
Endologix appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (12)
FDA medical device enforcement actions by Endologix
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 31, 2018 | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AF... | Endologix is notifying physicians of patient tailored surveillance recommenda... | Class I |
| Jul 31, 2018 | ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Ster... | Endologix is notifying physicians of patient tailored surveillance recommenda... | Class I |
| Jul 31, 2018 | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile E... | Endologix is notifying physicians of patient tailored surveillance recommenda... | Class I |
| Jul 31, 2018 | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile E... | Endologix is notifying physicians of patient tailored surveillance recommenda... | Class I |
| Jan 4, 2017 | AFX Endovascular AAA System Item Number Item Description F0070305 ... | Endologix updated information on the rates of Type III endoleaks and suggesti... | Class II |
| Jan 4, 2017 | AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA... | Endologix updated information on the rates of Type III endoleaks and suggesti... | Class II |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcate... | Endologix updated the Instructions for Use (IFU) and implemented modification... | Class II |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Sy... | Endologix updated the Instructions for Use (IFU) and implemented modification... | Class II |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIA | Endologix initiated a correction by updating reports for the cumulative clini... | Class II |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX En... | Endologix updated the Instructions for Use (IFU) and implemented modification... | Class II |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcat... | Endologix updated the Instructions for Use (IFU) and implemented modification... | Class II |
| Dec 27, 2016 | AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcate... | Endologix updated the Instructions for Use (IFU) and implemented modification... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.