Recall Z-2326-2026— INSPIREMD Inc

Name: FDA recall Z-2326-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Class II · Ongoing

Class II FDA medical device recall by INSPIREMD Inc, initiated 2026-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840. Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent..

Recalling firm: INSPIREMD Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-05-01
Firm location: Miami, FL, United States

Product description

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Reason for recall

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Data sourced from openFDA. This site is unofficial and independent of the FDA.