Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-1543-2017) was formally reported on March 29, 2017, with the manufacturer initiating the action on February 27, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Vascular, Inc. is listed as the recalling firm, operating out of Santa Rosa, CA. Federal records list the affected scope as 3331 devices.
The documented reason for this recall is: 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 gr… Distribution data in the federal record shows the product reached: 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 Re…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
3331 devices
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Vascular, Inc.. Units affected: 3331 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1543-2017.
Where was the recalled product distributed? ▼
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 Dominican Republic Ecuador Egypt El Salvador Finland France French Polynesia Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Mexico Montenegro Netherlands New Zealand Norway Oman Panama Paraguay Peru Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1543-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 29, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.