Lower riskMedical device recall · FDA · Published April 28, 2021
Medtronic Endurant II Stent Graft Recall: Incorrect Stentstop Assembly Risk
Medtronic recalls Endurant II stent grafts with incorrect stentstop assembly (18fr) that could cause device malfunction during vascular aneurysm treatment.
“Medtronic Endurant II Stent Graft Recall: Incorrect Stentstop Assembly Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62687-medtronic-endurant-ii-stent-graft-recall-incorrect-stentstop-assembly-risk. Based on FDA recall #Z-1976-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1976-2021%22&limit=1).
Medtronic Vascular, Inc. voluntarily recalled three Endurant II/IIs Stent Graft Systems on April 28, 2021, according to the FDA. The devices contain an incorrect stentstop assembly that may affect function.
The recall involves an incorrect stentstop assembly (18fr) used to build the delivery system component of the device. The correct stentstop assembly is 20fr.
Context
GovInfoNow's records show Medtronic Vascular, Inc. has six other recalls on record since September 13, 2017. Other recent recalls include the Medtronic IN.PACT AV Balloon Catheter Recall on March 23, 2022, and the Medtronic Endurant Stent Graft System Recall on December 21, 2021. Similar product recalls include the W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall on May 22, 2026, and the Bolton Medical RelayPro Thoracic Stent-Graft System Recall on April 22, 2026.
How to tell if you have this one
Check for model number ETBF3216C145E and serial numbers V30064787, V30064789, or V30064790 on the device packaging or documentation. This recall applies to specific units sold for vascular aneurysm treatment.
Brand
Medtronic
Product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the model number (ETBF3216C145E) and serial numbers (V30064787, V30064789, V30064790) on the device packaging or documentation.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide distribution in the state of GA. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1976-2021 (April 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1976-2021 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.