Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF23...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1543-2017.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1543-2017.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medtronic Vascular, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1543-2017.
Medtronic Vascular, Inc.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medtronic Vascular, Inc. Recall FAQ
Medtronic Vascular, Inc. is the subject of a medical implants safety report: Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF23.... The notice was published on February 27, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 3,331 units are potentially affected.