# P110023: Everflex Self-Expanding Peripheral Stent System (Everflex)

- Pathway: PMA
- Applicant: Medtronic Vascular, Inc.
- Decided: Mar 7, 2012 after 268 days
- Product code: NIP (Stent, Superficial Femoral Artery)
- 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
- Nov 20, 2023 · Class II · Z-0623-2024: Seal defects could compromise the ability of the product packaging to maintain sterility.
- Jul 14, 2022 · Class II · Z-1644-2022: Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
- May 23, 2016 · Class II · Z-2048-2016: Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08

Source page: https://510kreport.com/device/P110023
Methodology: https://510kreport.com/methodology