CGuard Prime Carotid Stent System recall (INSPIREMD Inc)

Medical deviceClass IIOngoing

Summary: INSPIREMD Inc is recalling CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030. Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

What is being recalled

CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

Why

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

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. (states named: 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)

How to tell if yours is affected

UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from INSPIREMD Inc · all medical device recalls · recalls from May 2026

Official FDA record