[pending] Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Pending LLM rewrite. Source: FDA_DEVICE Z-2326-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
The recalled product
- Product
- Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
- Manufacturer
- INSPIREMD Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 07290120281707
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution
Distributed nationwide across the United States.
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