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Recall Observatory FDA recall evidence

Device product

CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Z-2330-2026

May 01, 2026

Class II

Product summary

Firm
INSPIREMD Inc
Event
Event 98922
Status
Ongoing
Classification
Class II
Quantity
211 units
Official record key
device-enforcement:Z-2330-2026

Official wording

Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Code information: UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Field note

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