# P050025: Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System

- Pathway: PMA
- Applicant: Boston Scientific
- Decided: Oct 27, 2006 after 469 days
- Product code: NIM (Stent, Carotid)
- 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
- Jun 6, 2008 · Not classified · Z-2141-2008: Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failur
- May 1, 2007 · Not classified · Z-1161-2007: Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.
- May 15, 2006 · Not classified · Z-2089-2008: Tip may detach from stent delivery system.

Source page: https://510kreport.com/device/P050025
Methodology: https://510kreport.com/methodology