Medtronic Vascular, Inc. recalls Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

Recalled July 7, 2021 · FDA recall Z-1976-2021 · Medtronic Vascular

Hazard

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

Units

3 devices

Sold at

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

Description

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

Product

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

Manufacturer(s)

Medtronic Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →