FDAMay 1, 2026device
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
What to do
FDA enforcement status: Ongoing
Brands named
inspiremd
UPCs
07290120281745
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND08302026-05-01
- FDABrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND08402026-05-01
- FDACGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND10402026-05-01
- FDACGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND09302026-05-01
- FDACGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND10302026-05-01
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