FDA
Food and Drug Administration · Recall Z-2326-2026 · May 1, 2026Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
INSPIREMD Inc
The hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: 07290120281707UPC 07290120281707Would you have heard about this one?
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