CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Recall
- Recall Number
- Z-2330-2026
- Event Number
- 98922
- Firm
- INSPIREMD Inc
- FEI Number
- 3032814119
- Product Code
- NIM
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- May 1, 2026
- Posted
- June 5, 2026
- Address
- 6303 Waterford District Dr, Ste 215, Miami, FL, 33126-6004
Description
CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to [email protected] within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.
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.
211 units