Reported Mar 2, 2022 · Ongoing
Endurant, Endurant II and Endurant IIs Stent Graft System
Medtronic Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular, Inc. · 3850 Brickway Blvd · Santa Rosa, CA · 95403-8223
Is this the product you have?
Endurant, Endurant II and Endurant IIs Stent Graft System
163 of 163 products
| Model / number | Product as published |
|---|---|
ENBF2313C120EE | Medtronic Endurant Stent Graft System Model/ |
| — | ENBF2313C120EE |
| — | ENBF2313C145EE |
| — | ENBF2313C170EE |
| — | ENBF2316C120EE |
| — | ENBF2316C145EE |
| — | ENBF2316C170EE |
| — | ENBF2513C120EE |
| — | ENBF2513C145EE |
| — | ENBF2513C170EE |
| — | ENBF2516C120EE |
| — | ENBF2516C145EE |
| — | ENBF2516C170EE |
| — | ENBF2813C145EE |
| — | ENBF2813C170EE |
| — | ENBF2816C120EE |
| — | ENBF2816C145EE |
| — | ENBF2816C170EE |
| — | ENBF3216C120EE |
| — | ENBF3216C145EE |
- Amount recalled
- 14,629 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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