Neuroguard IEP® System NG-NV-7-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00851616007620), received between Jun 11, 2026 and Aug 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (5 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 ↗

2. Sep 4, 2025Class IIOpen, Classified

   Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.

   Z-0131-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2026Activation Failure; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50512696 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783352 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783136 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782949 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782787 ↗
• MalfunctionJun 11, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DEPOLOYMENT ISSUES OCCURRED WITH THE NEUROGUARD STENT IEP NG-NV-7-40, SPECIFICALLY THAT THE DEVICE WAS UNABLE TO DEPLOY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MULTIPLE ATTEMPTS WERE MADE IN A GOOD FAITH EFFORT TO COLLECT ADDITIONAL INFORMATION REGARDING THE EVENT. THE EVENT DATE WAS CONFIRMED AS DECEMBER 9, 2025. A STEP BY STEP ACCOUNT OF EXACTLY WHAT OCCURRED WITH DEPLOYMENT ISSUES WAS ASKED AND WAS UNKNOWN. THIS IS THE TOTALITY OF THE INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477395 ↗
• MalfunctionJun 11, 2026Misassembled During Installation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE DISTAL LEFT INTERNAL CAROTID ARTERY USING THE NEUROGUARD STENT IEP SYS NG-NV-7-40, THE STENT COULD NOT BE DEPLOYED AS INTENDED. THE TARGET LESION WAS CHARACTERIZED BY MODERATE CALCIFICATION, 50% STENOSIS, A LENGTH OF 40 MM, AND AN ARTERY DIAMETER OF 8.0 MM. EMBOLIC PROTECTION WAS USED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE THUMB WHEEL COULD NOT BE USED TO CONTINUE STENT DEPLOYMENT, AND ALTHOUGH THE FILTER COULD BE OPENED AND CLOSED, THE STENT ITSELF COULD NOT BE DEPLOYED. WE WERE ABLE TO PULL THE PIN FROM HANDLE AND SLOWLY ROLL THUMB WHEEL CLOSED, THE STENT ITSELF COULD NOT BE DEPLOYED. WE WERE ABLE TO PULL THE PIN FROM HANDLE AND SLOWLY ROLL THUMB WHEEL DOWN AND WERE ABLE TO GET FILTER OPENED, BUT UNABLE TO GET WHEEL TO CONTINUE TO DEPLOY STENT. WE CLOSED FILTER AND OPENED BACK UP AND STILL THE SAME. CLOSED FILTER AND BROUGHT DEVICE OUT. THE DEVICE WAS SAFETY REMOVED AND REPLACED WITH A NEW NEUROGUARD NG-NV-7-40 FROM THE SAME LOT WHICH DEPLOYED WITH NO PROBLEM TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477119 ↗
• MalfunctionJun 11, 2026Appropriate Device Problem Term/Code Not Available

  LIMITED INFORMATION WAS REPORTED THAT WHEN THE PHYSICIAN WENT TO DEPLOY THE NEUROGUARD STENT ISP SYS NV-NV-7-40, THE STENT WOULD NOT DEPLOY. PHYSICIAN KEPT USING THE THUMB WHEEL TO DEPLOY BUT THE STENT WAS NOT COMING OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED: DR. XXX WAS TREATING AN INTERNAL CAROTID ARTERY STENOSIS WITH THE NEUROGUARD. THE NEUROGUARD WAS ADVANCED TO THE TARGET LESION. THE 40 MICRON FILTER WAS DEPLOYED. WHEN ATTEMPTING TO NEXT DEPLOY THE NEUROGUARD STENT, THE THUMBWHEEL DID NOT MOVE, THE NEUROGUARD FILTER WAS CLOSED AND THE NEUROGUARD DELIVERY SYSTEM WAS REMOVED FROM THE CIRCULATION WITHOUT DIFFICULTY. A NEW NEUROGUARD WAS THEN USED TO TREAT THE PATIENT AND PERFORMED WITHOUT ANY ISSUES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25476891 ↗