Medtronic Endurant II Stent Graft Marker Detachment During Deployment
Medtronic recalls Endurant II stent graft systems: the radiopaque marker bond may detach during deployment. The recall affects 18 devices in U.S. and international distribution. No illnesses or injuries reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The product is a high-risk implanted device with a documented manufacturing defect. This meets the rubric criterion for High severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Vascular, Inc. is recalling certain Endurant II/Endurant IIs Stent Graft Systems. These devices are used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach. The recall was initiated due to a manufacturing defect: during stent graft deployment, the radiopaque marker bond may detach from the distal end of the graft cover.
The recall affects 18 devices across four models: ETCF3636C49EE, ETUF3214C102EE, ETBF3216C166EE, and ETUF3614C102E. These affected devices were distributed in the United States in eight states (Georgia, Massachusetts, Maryland, New York, South Carolina, Texas, Washington, and West Virginia) and internationally in twelve countries (Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, and the United Kingdom).
The FDA classified this as a Class II recall. No illnesses or injuries have been reported. The radiopaque marker is used to provide visualization during stent graft deployment, and its detachment could affect proper visualization and positioning of the device during the procedure.
The recalled product
- 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.
- Manufacturer
- Medtronic Vascular, Inc.
- Hazard
- marker-detachment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- V29778215
- Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791
- V29775792
- V29775793
- V29775794
- V29775795
- Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214
Distribution
Distributed in 8 states:
- GA
- MA
- MD
- NY
- SC
- TX
- WA
- WV
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