Neuroguard IEP® System NG-NV-6-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851616007644), received between Jul 10, 2026 and Aug 23, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (P240009); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 29, 2026Class IIOpen, Classified

   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.

   Z-2911-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2026Premature Activation; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation

  During the same procedure, two Neuroguard devices malfunctioned. A separate Medical Device Report is being made for each device. This report is for the second one. See report 3011471056-2026-00060 for the first. It was further reported that a second device (NG-NV-6-30 Neuroguard Stent IEP System) was attempted through the same 7Fr non-Contego catheter as the first device and the same resistance and inability to advance occurred, with the system not advancing past the distal end of the 7F catheter. The resistance was reported to have caused the system wire to buckle through the sheath retraction deployment knob. Resistance in the catheter caused an unsheathe and stent deployment inside the guide catheter. Both the 7Fr non-Contego catheter and Neuroguard were again successfully removed together without patient harm. A 6Fr non-Contego (Penumbra Benchmark) catheter and a 7x30 non-Contego (Cordis Precise Pro RX) stent were used to complete the procedure without issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50396436 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782474 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P240009. One submission often covers many models, so check the product and lot details in each record.

• Z-0131-2026 · Sep 4, 2025 · Open, Classified
  Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-N