Recall Z-0290-2022— Medtronic Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2021-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE. Reason: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-15
- Firm location
- Santa Rosa, CA, United States
Product description
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Reason for recall
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Data sourced from openFDA. This site is unofficial and independent of the FDA.