Medtronic Vascular, Inc. recalls Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145
Recalled Product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Hazard / Issue
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
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