CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
CGuard Prime Carotid Stent System, 10mmx30mm recalled by Inspiremd
Inspiremd is recalling CGuard Prime Carotid Stent System, 10mmx30mm, distributed nationwide in the US. The recall was initiated on 1 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2329-2026
- FDA event ID
- 98922
- Recalling firm
- Inspiremd, Miami, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 May 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +35 days |
| 17 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product as listed by the FDA
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaDistrict of ColumbiaFloridaGeorgiaHawaiiIllinoisIndianaKansasMassachusettsMarylandMichiganMissouriNorth CarolinaNew JerseyNevadaNew YorkOhioOregon
Questions about this recall
Why was it recalled?
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Which lots are affected?
UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Where was it 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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 98922This product is part of a recall event; the main page for the event is CGuard¿ Prime Carotid Stent System, 8mmx40mm recalled by Inspiremd.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CGuard¿ Prime Carotid Stent System, 8mmx40mm recalled by Inspiremd | Inspiremd | Other | Nationwide | |
| CLASS II | CGuard¿ Prime Carotid Stent System, 8mmx30mm recalled by Inspiremd | Inspiremd | Other | Nationwide | |
| CLASS II | CGuard Prime Carotid Stent System, 9mx30mm recalled by Inspiremd | Inspiremd | Other | Nationwide | |
| CLASS II | CGuard¿ Prime Carotid Stent System, 10mmx40mm recalled by Inspiremd | Inspiremd | Other | Nationwide | |
| CLASS II | CGuard Prime Carotid Stent System, 9mx40mm recalled by Inspiremd | Inspiremd | Other | Nationwide |
More recalls from Inspiremd
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CGuard Prime Carotid Stent System, 9mx40mm recalled by Inspiremd | Inspiremd | Other | Nationwide |
| Device | CLASS II | CGuard¿ Prime Carotid Stent System, 10mmx40mm recalled by Inspiremd | Inspiremd | Other | Nationwide |
| Device | CLASS II | CGuard Prime Carotid Stent System, 9mx30mm recalled by Inspiremd | Inspiremd | Other | Nationwide |
| Device | CLASS II | CGuard¿ Prime Carotid Stent System, 8mmx30mm recalled by Inspiremd | Inspiremd | Other | Nationwide |
| Device | CLASS II | CGuard¿ Prime Carotid Stent System, 8mmx40mm recalled by Inspiremd | Inspiremd | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |