Z-2325-2026Class II

Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

Name: Z-2325-2026 Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Creator: INSPIREMD Inc
Published: 2026-05-01
License: https://open.fda.gov/license/

INSPIREMD Inc / initiated 2026-05-01 / Open, Classified / root cause: design

FDA source

INSPIREMD Inc began a recall of Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830 on 2026-05-01. FDA classified it as Class II and gives the reason as "Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2325-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-01
Posted: 2026-06-05
Recalling firm: INSPIREMD Inc
Product: Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Product code: NIM Stent, Carotid
Reason for recall: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 190 units
Distribution: 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.
Product codes and lots: UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2325-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2325-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2326-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2327-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2328-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2329-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2330-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code NIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)