FDA-Device2021-07-07Class II
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Medtronic Vascular, Inc.
Hazard
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Sold states
U.S. Nationwide distribution in the state of GA. O.U.S.: None
Affected count
3 devices
Manufactured in
3850 Brickway Blvd, N/A, Santa Rosa, CA, United States
Products
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief