Medtronic Endurant II Stent Graft System Recall: Radiopaque Marker Detaches During
Medtronic recalls Endurant II stent graft systems with specific model numbers due to risk of radiopaque marker detaching during deployment, potentially causing complications.
Use caution until it’s fixed
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Contact the company
What happened, in plain English
Medtronic is recalling specific Endurant II stent graft systems because the radiopaque marker can detach during deployment. This could lead to complications if the marker becomes dislodged and is not properly visible during procedures. Read more at govinfonow.com/recall/62374-medtronic-endurant-ii-stent-graft-system-recall-radiopaque-marker-detaches.
Source Summary by GovInfoNow · govinfonow.com/recall/62374-medtronic-endurant-ii-stent-graft-system-recall-radiopaque-marker-detaches · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2135-2021
Cite this page
“Medtronic Endurant II Stent Graft System Recall: Radiopaque Marker Detaches During.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62374-medtronic-endurant-ii-stent-graft-system-recall-radiopaque-marker-detaches. Based on FDA recall #Z-2135-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2135-2021%22&limit=1).
Why it’s dangerous
During stent graft deployment, the radiopaque marker bond can detach from the distal end of the graft cover. This may cause the marker to become dislodged, making it difficult to track the device during procedures and potentially leading to complications.
Who’s affected
Patients who have received the recalled Endurant II stent graft systems for abdominal aortic or aortoiliac aneurysms are affected. Medical professionals using these systems during procedures are at risk if the marker detaches.
How to tell if you have this one
Check for model numbers: ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, or ETUF3614C102E. These systems were sold with specific serial numbers listed in the recall notice.
- Brand
Medtronic- Product
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2135-2021 | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.; Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882 | 18 devices |
| Z-2136-2021 | Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.; Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951; | 21 devices |
What to do — step by step
Check Product Model
Identify your stent graft system model number by checking the product label or documentation.
Contact Medtronic
Reach out to Medtronic directly to confirm if your specific model is recalled and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
FDA distribution: “U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Maryland, Massachusetts, New York, South Carolina, Texas, Washington, West Virginia.
Recall timeline
FDA published this recall 58 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2135-2021 (June 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2135-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.