FDA
Food and Drug Administration · Recall Z-2328-2026 · May 1, 2026Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
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, 9mx40mm Model/Catalog Number: CND0940
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI: 07290120281745UPC 07290120281745Would you have heard about this one?
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