FDA recall Z-1976-2021

Product

Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

Reason for recall

Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

Distribution

U.S. Nationwide distribution in the state of GA. O.U.S.: None

Key facts

Status

Terminated

Initiation date

2021-04-28

Report date

2021-07-07

Termination date

2024-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Rosa, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2021