INSPIREMD Inc
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →