FDAJune 7, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic vascularmedtronic
UPCs
0064316943996200643169780460
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter2026-04-21
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →