Reported Jun 17, 2026 · Ongoing
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
INSPIREMD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INSPIREMD Inc · 6303 Waterford District Dr Ste 215 · Miami, FL · 33126-6004
Is this the product you have?
CGuard Prime Carotid Stent System135cm10mmx30mm
- Model/Catalog NumberCND1030
- Lot codes and dates
- UDI07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- Amount recalled
- 114 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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