⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

INSPIREMD Inc: Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Medical DevicesSource: FDA (device) · Date: 2026-06-17

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
INSPIREMD Inc
Product
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Reason / hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.
Recall initiated
2026-05-01
Code info
UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Product quantity
291 units
Voluntary mandated
Voluntary: Firm initiated
City
Miami
State
FL
Country
United States
Event id
98922
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