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MEDICAL DEVICE RECALLMODERATE
CGuard Prime Carotid Stent System
InspireMD is recalling the CGuard Prime Carotid Stent System (Model CND0830) due to potential deployment complications.
What to do
Healthcare providers should stop using the affected stent delivery system and return all unused units to the manufacturer.
Why it was recalled
InspireMD is recalling the CGuard Prime Carotid Stent System due to potential complications during deployment, including high resistance or the inability to deploy the stent. The affected model is CND0830.
Is mine affected?
This recall covers the products below. If you have any of them, yours is affected.
| Product |
|---|
| CGuard Prime Carotid Stent System, 135cm, 10mmx30mm |
| Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm |
| Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm |
| CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm |
| CGuard Prime Carotid Stent System, 135cm, 9mx30mm |
| Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm |
Official source
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Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification