Recalled Neuroguard IEP 3-in-1 carotid stent systems with integrated filter may fail to open during procedures, risking loss of embolic protection. Affected units have specific reference numbers.
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
Contego Medical is recalling certain Neuroguard IEP 3-in-1 carotid stent systems because a wire-to-filter bond issue could cause the integrated filter to fail during procedures. This might lead to loss of embolic protection, which is critical for preventing complications during vascular surgery.
The integrated filter in the device may fail to open after sheath retraction due to a wire-to-filter bond issue. If this happens during a procedure, the system might not provide embolic protection, potentially causing complications like blockages or tissue damage.
Medical professionals who use the Neuroguard IEP 3-in-1 carotid stent systems for vascular procedures are most at risk if they have the recalled units. Patients undergoing these procedures with the affected devices could face complications.
Check the reference numbers listed in the recall: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40. The device includes specific lot numbers and unique identifiers.
Look for the reference numbers on the device packaging or label: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40.
Reach out to Contego Medical directly for further assistance or to confirm if your device is affected.
The integrated filter may fail to open after sheath retraction due to a wire-to-filter bond issue, which could lead to loss of embolic protection during procedures.
Check the reference numbers on the device: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40.
No immediate stop is required, but medical professionals should check if their device is affected and contact Contego Medical for guidance.
We’ve drafted a message you can send Contego Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2911-2026 — Contego Medical Contego Medical Hello, I own a Contego Medical that is covered by recall Z-2911-2026 from Contego Medical. 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.
