Recall Z-2135-2021— Medtronic Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2021-06-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-07
- Firm location
- Santa Rosa, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.