medical Class II Updated 2021-07-07

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;
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →