# P030025: Taxus EXPRESS2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Mar 4, 2004 after 259 days
- Product code: NIQ (Coronary Drug-Eluting Stent)
- Device class: 3
- Recalls of this device: 1 (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
- Jul 1, 2004 · Not classified · Z-1052-04: On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.

Source page: https://510kreport.com/device/P030025
Methodology: https://510kreport.com/methodology