FDA Devices recall · Reported March 29, 2017
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternati
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as thi…
Medtronic Vascular, Inc. recalled Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETB… - a moderate-severity action.
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETB… was recalled by Medtronic Vascular, Inc. in March 29, 2017. Reason: Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifur…. Check the official notice for the remedy. Verify recall #Z-1543-2017 with the FDA Devices before acting.
The recall
Medtronic Vascular, Inc. issued this moderate-severity FDA Devices recall-Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifur….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- March 29, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1543-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
Reason for recall
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1543-2017 |
| Date reported | March 29, 2017 |
| Date initiated | February 27, 2017 |
| Recalling firm | Medtronic Vascular, Inc. |
| Firm location | Santa Rosa, CA |
| Affected scope | 3331 devices |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Argentina Armenia Australia Austria Belgium Brazil Bulgaria Canada China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dom… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1543-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026