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MEDICAL DEVICE RECALLMODERATE
CGuard Prime Carotid Stent System
InspireMD recalls CGuard Prime Carotid Stent System due to deployment complications.
What to do
Do not use the affected stent system. Contact InspireMD for instructions on returning the product and obtaining a replacement.
Why it was recalled
InspireMD is recalling the CGuard Prime Carotid Stent System because the stent delivery system may encounter complications during deployment, resulting in high resistance or inability to deploy the stent.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840 | 07290120281707 | Z-2326-2026 |
| Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830 | 07290120281691 | Z-2325-2026 |
| CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 | 07290120281738 | Z-2327-2026 |
| Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940 | 07290120281745 | Z-2328-2026 |
| CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 | 07290120281783 | Z-2330-2026 |
| CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030 | 07290120281776 | Z-2329-2026 |
Where it was sold
Distributed nationwide.
Official source
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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification