Miami, FL, United States
INSPIREMD Inc recalls
1 recall recorded since 2018, most recently on 1 May 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 May 2026
- Reason
- Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2326-2026, Z-2325-2026, Z-2327-2026, Z-2330-2026, Z-2328-2026, Z-2329-2026
- Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
- Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
- CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
- CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
- Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
- CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.