# FDA recall Z-2325-2026

> **INSPIREMD Inc** · Class II · device recall initiated 2026-05-01.

## Product

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

## Reason for recall

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.

## Key facts

- **Recall number:** Z-2325-2026
- **Recalling firm:** INSPIREMD Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-01
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2026

## Citation

> MORVS. FDA recall Z-2325-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2325-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*