Reported Jul 7, 2021 · Terminated
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
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 II/IIs Stent Graft SystemSTENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms
- Lot codes and dates
- Model NumberETBF3216C145E
- GTIN00613994990983
- Serial Numbers
V30064787V30064789V30064790
- Amount recalled
- 3 devices
Where it was sold
- Nationwide
- GA
Why it was recalled
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
This product could cause temporary or reversible health problems — stop using it.
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