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.
Reported: August 4, 2021 Initiated: June 7, 2021 #Z-2135-2021
Product Description
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.
Reason for Recall
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Details
- Recalling Firm
- Medtronic Vascular, Inc.
- Units Affected
- 18 devices
- 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.
- Location
- Santa Rosa, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Vascular, Inc.. Units affected: 18 devices.
Why was this product recalled? ▼
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2135-2021.
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