Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
Check against the official notice below — it lists the full affected range.
Medtronic Vascular, Inc. is recalling 21 Endurant IIs Stent Graft System devices used to treat infrarenal abdominal aortic or aortoiliac conditions. The recall was initiated after product complaint investigation determined that a radiopaque marker bond detached from the distal end of the graft cover during stent graft deployment in one of the devices.
The affected devices were distributed in the United States in Georgia, Massachusetts, Maryland, New York, South Carolina, Texas, Washington, and West Virginia, as well as internationally in Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, and the United Kingdom. The recalled units include two model types with specific serial numbers identified in the recall notice. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Reason for recall: During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover. Distribution: U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom. Quantity: 21 devices Lot/code info: Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.