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U.S. Department of Health and Human Services

Class 2 Device Recall CGuard Prime Carotid Stent System

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 Class 2 Device Recall CGuard Prime Carotid Stent Systemsee related information
Date Initiated by FirmMay 01, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2329-2026
Recall Event ID 98922
PMA NumberP240029 
Product Classification Stent, carotid - Product Code NIM
ProductCGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Code Information UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
FEI Number 3032814119
Recalling Firm/
Manufacturer		 INSPIREMD Inc
6303 Waterford District Dr Ste 215
Miami FL 33126-6004
For Additional Information ContactInspireMD Customer Service
1888-776-6804
Manufacturer Reason
for Recall		Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
FDA Determined
Cause 2		Component design/selection
ActionOn May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to USSupport@inspiremd.com within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.
Quantity in Commerce114 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NIM
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