INSPIREMD recalls CGuard Prime Carotid Stent System (CND1040) due to potential deployment complications. Affected units were manufactured between Feb 2025 and Feb 2026. Consumers should contact for details.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
INSPIREMD is recalling its CGuard Prime Carotid Stent System (model CND1040) because the stent delivery system might have trouble deploying the stent, which could cause high resistance or failure. This could lead to medical complications if the stent doesn't deploy properly.
The stent delivery system may encounter complications during deployment, causing high resistance or inability to deploy the stent. This could lead to medical complications if the stent fails to function correctly during a procedure.
Patients who have received this specific carotid stent system model (CND1040) manufactured between February 2025 and February 2026 are affected. Medical professionals using this device for procedures are at risk.
Check for the model number CND1040 on the device packaging or label. The product was manufactured between February 2025 and February 2026 with UDI: 07290120281783.
Identify the model number CND1040 and manufacturing dates between February 2025 and February 2026.
The recall states the stent delivery system may encounter complications during deployment, which could result in high resistance or inability to deploy the stent. This could lead to medical complications.
The recall does not specify a remedy, so contact INSPIREMD directly for further instructions.
The product was manufactured between February 2025 and February 2026.
We’ve drafted a message you can send INSPIREMD to request your refund or repair — edit it as you like.
Subject: Recall Z-2330-2026 — INSPIREMD INSPIREMD Hello, I own a INSPIREMD that is covered by recall Z-2330-2026 from INSPIREMD. 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.