# P100021: Medtronic Vascular Endurant Stent Graft System

- Pathway: PMA
- Applicant: Medtronic Vascular
- Decided: Dec 16, 2010 after 195 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 15, 2021 · Class II · Z-0291-2022: Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
- Oct 15, 2021 · Class II · Z-0290-2022: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
- Oct 15, 2021 · Class II · Z-0292-2022: Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
- Jun 7, 2021 · Class II · Z-2136-2021: During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
- Jun 7, 2021 · Class II · Z-2135-2021: During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
- Feb 27, 2017 · Class II · Z-1543-2017: Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of s

Source page: https://510kreport.com/device/P100021
Methodology: https://510kreport.com/methodology