CGuard Prime 10mm by 40mm carotid stents may fail deployment
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
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: FDA Class II recall where a stent may fail to deploy during a carotid procedure, a risk of harm with no injuries reported in the source.
Plain-English summary
The CGuard Prime Carotid Stent System, 135 cm, 10 mm x 40 mm, model/catalog number CND1040, UDI 07290120281783, is being recalled. The action covers 211 units, spanning all lots and serial numbers manufactured between 02/03/2025 and 02/23/2026.
The stated reason is that the stent delivery system may encounter complications during deployment, which may result in high resistance or an inability to deploy the stent. The FDA classified the action as Class II.
Distribution was nationwide in the United States across a large number of states. The stent systems are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, UDI and manufacturing date range above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
- Manufacturer
- INSPIREMD Inc
- Affected units
- 211
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: 07290120281783
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution
Part of a larger recall action
This product is one of 6 recalled by INSPIREMD Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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