Medtronic Vascular, Inc. recalls Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
- Recall date
- April 28, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1976-2021
- FDA classification
- Class II
- Brand / firm
- Medtronic Vascular, Inc.
- Sold / distributed
- U.S. Nationwide distribution in the state of GA. O.U.S.: None
Why it was recalled
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
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