CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Summary
The FDA issued a Class II for CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND by INSPIREMD Inc. Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent..
Details
Source
Device Recall
External ID
Z-2330-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Lot/Code Info: UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Quantity Affected: 211 units
Reason for Recall
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-01
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
INSPIREMD Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (INSPIREMD Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INSPIREMD Inc have FDA actions?
INSPIREMD Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2330-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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