# P050019: Carotid Wallstent Monorail Endoprosthesis

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Oct 23, 2008 after 1,248 days
- Product code: NIM (Stent, Carotid)
- Device class: 3
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has 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 7, 2025 · Class I · Z-2273-2025: Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (

Source page: https://510kreport.com/device/P050019
Methodology: https://510kreport.com/methodology