Official recall notice
FDA DeviceClass IINotable
FDA Recall: CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
- Recall date
- 2026-06-17
- Brand
- INSPIREMD Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Recommended action
What to do
114 units
Product description
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.