INSPIREMD recalls CGuard Prime carotid stent systems (model CND0830) due to deployment complications. Affected units were sold between Feb 2025 and Feb 2026. Contact for remedy.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD recalls CGuard Prime carotid stent systems with model number CND0830 that may have deployment complications. This could prevent proper stent placement, risking health issues during medical procedures.
The stent delivery system may face high resistance or fail to deploy the stent properly during medical procedures. This could lead to incomplete treatment or complications requiring additional interventions.
Patients undergoing carotid stent procedures who own the recalled model CND0830. Medical professionals using the device for procedures are most at risk.
Check for model number CND0830 on the device. Affected units were manufactured between February 2025 and February 2026. The unique device identifier (UDI) starts with 07290120281691.
Identify the model number and production dates to confirm if your device is affected.
Reach out to INSPIREMD for specific guidance on next steps after verification.
The recall applies to specific models manufactured between February 2025 and February 2026. If your device matches the model and dates, contact INSPIREMD for details.
The official recall record does not specify a remedy. Contact INSPIREMD directly for instructions.
Check the model number (CND0830) and production dates (February 2025 to February 2026) on your device. The unique device identifier (UDI) starts with 07290120281691.
We’ve drafted a message you can send CGuard Prime to request your refund or repair — edit it as you like.
Subject: Recall Z-2325-2026 — CGuard Prime CGuard Prime Hello, I own a CGuard Prime that is covered by recall Z-2325-2026 from CGuard Prime. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
