# P200026: Abre Venous Self-expanding Stent System

- Pathway: PMA
- Applicant: Medtronic Vascular, Inc.
- Decided: Oct 21, 2020 after 177 days
- Product code: QAN (Stent, Iliac Vein)
- Device class: 3
- Recalls of this device: 3 (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
- Dec 4, 2025 · Class II · Z-1098-2026: Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
- Nov 19, 2021 · Class II · Z-0464-2022: There have been reports of stent migration.
- Mar 16, 2021 · Class II · Z-1532-2021: Incorrect size printed on the device; packaging is labeled correctly.

Source page: https://510kreport.com/device/P200026
Methodology: https://510kreport.com/methodology