Neuroguard IEP® System NG-NV-6-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00851616007651), received between Apr 15, 2026 and Sep 18, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Malposition of Device

  It was reported that the NEUROGUARD STENT IEP SYSTEM NG-NV-6-40 was implanted in the proximal right internal carotid artery for a severe, calcified 80% stenotic plaque lesion measuring 36mm in length in a 6.8mm vessel in a patient with a history of prior stroke. A non-Medtronic (Asahi Fubuki) sheath was used. Embolic protection was used. The vessel was pre- and post-dilated. No resistance was encountered when advancing the device. The IFU (Instruction for Use) was followed during preparation, procedure, and post-procedure without issue. The stent was optimally positioned across the target lesion before deployment but migrated north during implantation. The stent remained in the vessel, and two non-Medtronic (Boston Wallstents) were placed to extend. Computed tomography was performed in the procedure room after the procedure and Physician confirmed no large-vessel occlusion (LVO) or bleeding. Following placement of the two non-Medtronic (Boston Wallstents) stents, the patient had some left-sided weakness. Integrilin was administered, and the symptoms were improving at the last assessment.The following additional information was later reported:Femoral entry route. Embolic protection

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 50812889 ↗
• MalfunctionSep 9, 2026Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702119 ↗
• MalfunctionJul 14, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25819104 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785522 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782886 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782879 ↗
• InjuryJun 10, 2026Off-Label Use

  IT WAS REPORTED THAT A PATIENT WITH A CALCIFIED LESION EXHIBITING MODERATE CALCIFICATION AND MINIMALTORTUOSITY IN THE MID RIGHT CAROTID ARTERY UNDERWENT RIGHT CAROTID ARTERY STENT PLACEMENT USING THE NEUROGUARD NG-NV-6-40 STENT. THE PHYSICIAN NAVIGATED A NON-MEDTRONIC (WALRUS) BALLOON GUIDE CATHETER TO THE RIGHT COMMON CAROTID ARTERYAND A NON-MEDTRONIC (ARISTOTLE 14) GUIDEWIRE TO THE RIGHT INTERNAL CAROTID ARTERY. THE PHYSICIAN ELECTED TO NOT USE ADISTAL PROTECTION DEVICE IN THIS CASE. THE NEUROGUARD WAS THEN PREPPED ACCORDING TO THE IFU. THE PHYSICIAN ELECTED TO NOT INFLATE THE BALLOON GUIDE CATHETER THE ENTIRE CASE. THE PHYSICIAN THEN TRACKED NEUROGUARD TO THE LESION. THEGUIDEWIRE WAS HAVING TROUBLE STAYING DISTAL AND HAD REDUCED PURCHASE DISTAL TO THE TIP OF THE NEUROGUARD BYAPPROXIMATELY 2 OR 3CM. THE REP THEN INSTRUCTED THE PHYSICIAN ON HOW TO START DEPLOYING THE DEVICE. HE USED THE THUMBWHEEL TO UNSHEATH THE BLUE OUTER SHEATH TO THE DISTAL TIP OF THE STENT AND EXPOSE THE FILTER. AT THIS TIME THE REP INSTRUCTEDPHYSICIAN TO USE THE ROTATION KNOB TO OPEN THE FILTER. THE PHYSICIAN ELECTED TO NOT USE THE FILTER AND WANTED TO GO AHEADWITH STENT DEPLOYMENT. PHYSICIAN FINISHED DEPLOY

  Patient problems: Ischemia Stroke

  MAUDE report 25459588 ↗
• MalfunctionMay 29, 2026Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT CAROTID STENOSIS, THE PHYSICIAN INSERTED THE NEUROGUARD STENT IEP SYSTEM INTO A 9FR MOMA CEREBRAL PROTECTION DEVICE AND FELT SOME RESISTANCE IN THE PROXIMAL SECTION OF THE CATHETER DURING DELIVERY. THE REPORTED DEVICES AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE VESSEL WAS NOT TORTUOUS. THE PHYSICIAN TOOK THE NEUROGUARD OUT AND THE YELLOW DISTAL TIP WAS NOT ATTACHED. HE THEN REMOVED THE MOMA AND IT WAS STUCK IN IT. THE DEVICES WERE REMOVED FROM THE PATIENT, WITH NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED: LESION/VESSEL SITE ASSOCIATED: LEFT ICA STENOSIS, THE NEUROGUARD GOT FRIECTION ABOUT LESS THAT HALFWAY THROUGH MOMA. HOW WAS THE PROCEDURE COMPLETED? REMOVED MOMA AND USED BMX 96 WITH NEUROGUARD. ARE THERE ANY PRE-OP ANGIOS AND STILL IMAGES AVAILABLE? UNFORTUNATELY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333349 ↗
• MalfunctionApr 15, 2026Difficult or Delayed Separation

  EVENT DESCRIPTION VERBAL REPORT FROM THE SALES REPRESENTATIVE WHO WAS NOT PRESENT FOR THE CASE. PHYSICIAN TRIED TO USE NEUROGUARD AFTER RE-ESTABLISHING FLOW IN THE ICA BUT THE MEGA BALLAST SHEATH PROLAPSED OUT OF POSITION. PHYSICIAN DECIDED TO REMOVE THE NEUROGUARD SYSTEM AND MEGA BALLAST TOGETHER. THE PHYSICIAN THINKS THAT WHEN THE SYSTEM APPROACHED THE GROIN SHEATH THE NEUROGUARD STENT DEPLOYED INTO THE DESCENDING AORTA. INVESTIGATION DEVICE DISCARDED, NO DEVICE INVESTIGATION DEVICE POSSIBLE. THERE IS NO REPORT OF THE NEUROGUARD PRODUCT MALFUNCTIONING. THE INADVERTENT STENT DEPLOYMENT APPEARS TO BE CASED BY THE WITHDRAWAL ACTIONS RELATED TO THE REMOVAL OF THE SYSTEM DUE TO THE PROLAPSED SHEATH. SUSPECTED PRIMARY CAUSE: THE MOST PROBABLE CONTRIBUTING FACTOR FOR THE STENT DEPLOYMENT WAS THE WITHDRAWAL ACTIONS (THE STENT BEING PULLED OFF BY THE GROIN SHEATH) RELATED TO THE PROLAPSED SHEATH. CONCLUSIONS THE NEUROGUARD PRODUCT WAS USED WITH A MEGA BALLAST SHEATH WHICH PROLAPSED. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE OF A NEUROGUARD DEVICE MALFUNCTION. THE UNINTENDED REMOVAL OF THE ENTIRE SYSTEM (MEGA BALLAST SHEATH AND NEUROGUARD SYSTEM) CREATED A SCENARIO WHERE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888306 ↗