Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. 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 is recalling 18 Endurant II Stent Graft System devices used to treat infrarenal conditions. During deployment of these stent grafts, the radiopaque marker bond—which helps doctors visualize the device during placement—detached from the distal end of the graft cover. The affected devices were distributed in eight U.S. states (Georgia, Massachusetts, Maryland, New York, South Carolina, Texas, Washington, and West Virginia) and twelve countries outside the U.S.
The recall involves four specific model reference numbers with identified serial numbers. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Reason for recall: 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: 18 devices Lot/code info: Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.