United StatesCGuard Prime Carotid Stent System by INSPIREMD (models CND0830, CND0840, CND0930, CND0940, CND1030, CND1040; sizes 8–10 mm × 30–40 mm, 135 cm) with UDIs 07290120281691, 07290120281707, 07290120281738, 07290120281745, 07290120281776, 07290120281783 and all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 is recalled. The stent delivery system may encounter complications during deployment that can cause high resistance or inability to deploy the stent.
What's being recalled
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Recalling firm: INSPIREMD Inc, Miami, FL, United States.
How to identify it
UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
The hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)