Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF282...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0291-2022.
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0291-2022.
Recall ongoing. Follow firm instructions.
✅ 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-0291-2022.
Medtronic Vascular, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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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 II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF282.... The notice was published on October 15, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 511 units are potentially affected.