FDA recall, , Moderate risk
CGuard Prime Carotid Stent System
The CGuard Prime Carotid Stent System may encounter complications during deployment, causing high resistance or inability to deploy.
Summary by Recall Canary from the FDA notice
What happened
INSPIREMD Inc of Miami, Florida, began a recall of the CGuard Prime Carotid Stent System on May 1, 2026, because the stent delivery system may encounter complications during deployment, which may result in high resistance or inability to deploy the stent. The FDA added the recall to its Enforcement Report on June 5, 2026. The products were distributed nationwide in states including Arkansas, California, Florida, Georgia, Illinois, New York, Texas, and Washington, D.C.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
6 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm
- UDI-DI
- 07290120281707
- Model/Catalog number
- CND0840
- Lot code
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm
- UDI-DI
- 07290120281691
- Model/Catalog number
- CND0830
- Lot code
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/
- UDI-DI
- 07290120281738
- Catalog code
- CND0930
- Lot code
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
CGuard Prime Carotid Stent System, 135cm, 9mx40mm
- UDI-DI
- 07290120281745
- Model/Catalog number
- CND0940
- Lot code
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/
- UDI-DI
- 07290120281783
- Catalog code
- CND1040
- Lot code
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/
- UDI-DI
- 07290120281776
- Catalog code
- CND1030
- Lot code
- all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia.
- Company
- INSPIREMD IncMiami, Florida
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98922
- Recall numbers
- Z-2325-2026 to Z-2330-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
