medical MODERATE Updated 2026-06-17

INSPIREMD Inc recalls CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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