Medtronic Endurant Stent Graft System Recall: Taper Tip Detachment Risk
Medtronic recalls Endurant, Endurant II, and Endurant IIs stent graft systems with specific batch numbers that may detach during implant, requiring removal or leaving behind in patients.
Use caution until it’s fixed
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Contact the company
What happened, in plain English
Medtronic is recalling Endurant, Endurant II, and Endurant IIs stent graft systems with specific batch numbers that have a risk of the taper tip detaching during implant. This could require a secondary intervention to remove the tip or leave it behind in the patient. Read more at govinfonow.com/recall/61413-medtronic-endurant-stent-graft-system-recall-taper-tip-detachment-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61413-medtronic-endurant-stent-graft-system-recall-taper-tip-detachment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0657-2022
Cite this page
“Medtronic Endurant Stent Graft System Recall: Taper Tip Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61413-medtronic-endurant-stent-graft-system-recall-taper-tip-detachment-risk. Based on FDA recall #Z-0657-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0657-2022%22&limit=1).
Why it’s dangerous
The taper tip assembly in specific batches can detach during the implant procedure. If detached, it may require a second intervention to remove it via endovascular retrieval or surgery. In some cases, the tip may be intentionally left behind by the physician if not easily removable.
Who’s affected
Patients who have received the recalled stent graft systems for infrarenal abdominal aortic or aortoiliac aneurysms using endovascular approaches are affected. Medical professionals performing the procedure are at highest risk.
How to tell if you have this one
Check the model/serial numbers listed in the recall notice. The affected products include Endurant, Endurant II, and Endurant IIs stent graft systems with specific batch codes and serial numbers provided in the recall list.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Details
Identify the model and serial numbers from the recall list to confirm if your device is affected.
Contact Medtronic
Reach out to Medtronic directly for guidance on next steps if your device is listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months 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.
Questions people ask
Do I need to take action if I have the device?
Yes, contact Medtronic to determine if your device is affected and follow their instructions.
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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-0657-2022 (December 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0657-2022 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.