Neuroguard IEP® System NG-0740-140-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00851616007613), received between Jul 25, 2025 and Aug 30, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (16 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2026Accessory Incompatible; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50512701 ↗
• MalfunctionAug 3, 2026Break; Activation Failure; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111153 ↗
• MalfunctionJul 14, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25819025 ↗
• MalfunctionJul 10, 2026Use of Device Problem; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787271 ↗
• MalfunctionJul 10, 2026Activation Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE NEUROGUARD STENT IEP SYS NG-0740-140-2, THE DEVICE WAS DIFFICULT TO SET UP AND THE FILTER DID NOT FULLY OPEN TO FLUSH. AFTER CLOSING IT AND TRYING AGAIN, THE FILTER DID NOT OPEN EVEN THOUGH THE THUMB WHEEL WAS STILL ABLE TO BE TURNED. THE DEVICE WAS NEVER IMPLANTED AND WAS NOT USED IN A PATIENT. THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785642 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785549 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785494 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785094 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25784308 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783688 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783526 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783415 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783290 ↗
• MalfunctionJul 10, 2026Activation Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE INVOLVING THE NEUROGUARD STENT IEP SYS NG-0740-140-2, THE FILTER PARTIALLY OPENED AND THEN "SNAPPED" CLOSED, AND THE WIRE THAT ACTUATES THE FILTER SNAPPED AND POKED THROUGH THE FILTER. THEISSUE OCCURRED WHILE ATTEMPTING TO OPEN THE FILTER ON THE BACK TABLE, SUBMERGED IN A SALINE BOWL WITH THE STYLET IN PLACE, AND THE WIRE SNAPPED AS THE ACTUATOR KNOB WAS FULLY ENGAGED. A .014 4-7MM NON-MEDTRONIC (ABBOTT EMBOSHIELD) FILTER WIRE WAS INTENDED TO BE USED. THE DEVICE WAS NEVER IMPLANTED OR INTRODUCED INTO THE PATIENT. THE CASE WAS COMPLETED USING AN NG-0640-140-2 NEUROGUARD DEVICE WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783093 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783022 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782973 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782815 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782755 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782723 ↗
• MalfunctionJun 11, 2026Misassembled During Installation

  IT WAS REPORTED THAT DURING TREATMENT OF A FIBROUS LESION IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY WITH THE NEUROGUARD STENT IEP SYS NG-0740-140-2, THERE WAS A DELAY IN SURGERY OF 10 MINUTES DUE TO THE INABILITY TO DEPLOY THE DEVICE. VESSEL MORPHOLOGY INCLUDED 70% STENOSIS, 15MM LENGTH, 6 MM DIAMETER, MINIMAL TORTUOSITY AND CALCIFICATION. A 6F NON-CONTEGO (COOK SHUTTLE) SHEATH WAS USED. A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE WAS USED. THE VESSEL WAS NOT PRE-DILATED OR POST-DILATED AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE THRUMBSCREW/LOCK-PIN WAS CHECKED AND REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. NO STENT STRUTS WERE EXPOSED OR VISIBLE ON REMOVAL, AND NO INTERVENTION WAS REQUIRED FOR REMOVAL OF THE DEVICE. THE DEVICE WAS SAFETY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETELY USING A NEW NEUROGUARD DEVICE. NO PATIENT COMPLICATION HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP: THE SHEATH DID NOT RETRACT AT ALL AS THE THUMB WHEEL WAS SPINNING FREELY. THE FILTER WAS NOT EXPOSED AS THE OUTER SHEATH DID NOT RETRACT AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480326 ↗
• MalfunctionMay 3, 2026Mechanical Jam

  EVENT DESCRIPTION IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE USING THE NEUROGUARD STENT IEP SYSTEM TO TREAT PLAQUE IN THE LEFT INTERNAL CAROTID ARTERY WITH AN 80% STENOSIS (LESION LENGTH 30MM, VESSEL DIAMETER 7MM, MODERATE TORTUOSITY), A NON-MEDTRONIC (ABBOTT NAV 6) EMBOLIC PROTECTION DEVICE WAS DEPLOYED AND THE NEUROGUARD SYSTEM WAS ADVANCED THROUGH A 7FR TOUR GUIDE SHEATH. THE FILTER WAS DEPLOYED, THE STENT WAS DEPLOYED, AND POST-DILATION WAS PERFORMED. AFTER THE INTEGRATED FILTER OF THE NEUROGUARD WAS CLOSED, THE PHYSICIAN WAS UNABLE TO REMOVE THE NEUROGUARD DELIVERY SYSTEM BECAUSE IT WOULD NOT TRACK BACK OVER THE NAV 6 WIRE. (THIS IS BELIEVED TO BE DUE TO THE TOUR GUIDE SHEATH COLLAPSING ON THE NEUROGUARD DEVICE AND HINDERING RELATIVE MOVEMENT). AS A RESULT, THE PHYSICIAN REMOVED EVERYTHING AS A UNIT. THE DELIVERY SYSTEM WAS SAFELY REMOVED SUCCESSFULLY WITHOUT INJURY/INTERVENTION AND THE PROCEDURE WAS COMPLETED. NO VESSEL DAMAGE REPORTED. INVESTIGATION THE DEVICE WAS NOT RETURNED, BUT INFORMATION RECEIVED SUGGESTS THAT THE REPORTED SITUATION MAY HAVE BEEN RELATED TO USE OF A TOUR GUIDE SHEATH THAT BROKE DURING THE PROCEDURE. THE LOT HISTORY DOES NOT INDICATE PRODUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062451 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION (AS REPORTED). IT WAS REPORTED THAT A NEUROGUARD STENT IEP SYS NG-0740-140-2 WAS USED TO TREAT A PATIENTS RIGHT PROXIMAL CAROTID ARTERY, WHICH HAD A SEVERELY CALCIFIED LESION WITH 90% STENOSIS. POST-OP, THE PATIENT SUFFERED A STROKE (LATER DETERMINED THAT STROKE SYMPTOMS STARTED PRIOR TO THE INTRODUCTION OF THE NEUROGUARD DEVICE). THE PATIENT WAS ADMITTED TO HOSPITAL. THE ISSUE WAS RESOLVED. INVESTIGATION: SUMMARY OF CONVERSATION BETWEEN DR. (B)(6) AND DR. (B)(6): THE TARGET LESION WAS A HEAVILY CALCIFIED 90 PERCENT STENOSIS OF THE R ICA. AN ON-LABEL SPIDER DISTAL EMBOLIC PROTECTION DEVICE WAS DEPLOYED WITHOUT INCIDENT. DUE TO THE LESION CALCIFICATION AND DEGREE OF STENOSIS A PRE-DILATION WAS PERFORMED WITH A STANDARD ANGIOPLASTY BALLOON. NEXT, DUE TO THE SEVERE CALCIFICATION, AN OFF-LABEL USE OF SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED. IMPORTANTLY, AN EXCESSIVE AMOUNT OF MANIPULATION OF THE SHOCKWAVE CATHETER WAS REQUIRED TO DELIVER THE SHOCKWAVE BALLOON TO THE TREATMENT SITE. DURING THE SHOCKWAVE (IVL) THE PATIENT BECAME SYMPTOMATIC ON THE PROCEDURE TABLE WHICH WAS BEFORE THE NEUROGUARD STENT DELIVERY SYSTEM ENTERED THE BODY. THE PROCEDURE WAS CO

  Patient problems: Stroke/CVA

  MAUDE report 24273253 ↗
• MalfunctionAug 22, 2025Difficult to Open or Close; Difficult to Open or Close

  DURING A CAROTID ARTERY STENTING PROCEDURE, THE PHYSICIAN EXPERIENCED INCONSISTENT DEPLOYMENT OF THE NEUROGUARD FILTER. WHILE NO ADVERSE CLINICAL OUTCOME WAS REPORTED, A POSSIBLE POTENTIAL PERFORMANCE VARIATION WAS EXPERIENCED. THE NEUROGUARD FILTER DID NOT FULLY OPEN UPON RETRACTION OF THE OUTER SHEATH AND FULL ACTUATION OF THE FILTER WHEEL, RESULTING IN INCOMPLETE FILTER APPOSITION UNTIL AFTER PARTIAL OR FULL STENT DEPLOYMENT. IT SHOULD BE NOTED THAT A DISTAL PRIMARY FILTER IS REQUIRED TO BE IN PLACE AS PER THE IFU. THE CONTEGO FILTER OPENING CHALLENGES COULD LEAD TO MINOR PROCEDURAL DELAYS, DEVICE REMOVAL, OR THE NEED TO USE ALTERNATIVE STENTS. NO ADVERSE PATIENT OUTCOMES WERE REPORTED, AND ARE NOT ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878225 ↗
• MalfunctionJul 25, 2025Difficult to Open or Close; Difficult to Open or Close

  DURING A CAROTID ARTERY STENTING PROCEDURE, THE PHYSICIAN EXPERIENCED INCONSISTENT DEPLOYMENT OF THE NEUROGUARD FILTER. WHILE NO ADVERSE CLINICAL OUTCOME WAS REPORTED, A POSSIBLE POTENTIAL PERFORMANCE VARIATION WAS EXPERIENCED. THE NEUROGUARD FILTER DID NOT FULLY OPEN UPON RETRACTION OF THE OUTER SHEATH AND FULL ACTUATION OF THE FILTER WHEEL, RESULTING IN INCOMPLETE FILTER APPOSITION UNTIL AFTER PARTIAL OR FULL STENT DEPLOYMENT. IT SHOULD BE NOTED THAT A DISTAL PRIMARY FILTER IS REQUIRED TO BE IN PLACE AS PER THE IFU. THE CONTEGO FILTER OPENING CHALLENGES COULD LEAD TO MINOR PROCEDURAL DELAYS, DEVICE REMOVAL, OR THE NEED TO USE ALTERNATIVE STENTS. NO ADVERSE PATIENT OUTCOMES WERE REPORTED, AND ARE NOT ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613847 ↗
• MalfunctionJul 25, 2025Difficult to Open or Close; Difficult to Open or Close

  DURING A CAROTID ARTERY STENTING PROCEDURE, THE PHYSICIAN EXPERIENCED INCONSISTENT DEPLOYMENT OF THE NEUROGUARD FILTER. WHILE NO ADVERSE CLINICAL OUTCOME WAS REPORTED, A POSSIBLE POTENTIAL PERFORMANCE VARIATION WAS EXPERIENCED. THE NEUROGUARD FILTER DID NOT FULLY OPEN UPON RETRACTION OF THE OUTER SHEATH AND FULL ACTUATION OF THE FILTER WHEEL, RESULTING IN INCOMPLETE FILTER APPOSITION UNTIL AFTER PARTIAL OR FULL STENT DEPLOYMENT. IT SHOULD BE NOTED THAT A DISTAL PRIMARY FILTER IS REQUIRED TO BE IN PLACE AS PER THE IFU. THE CONTEGO FILTER OPENING CHALLENGES COULD LEAD TO MINOR PROCEDURAL DELAYS, DEVICE REMOVAL, OR THE NEED TO USE ALTERNATIVE STENTS. NO ADVERSE PATIENT OUTCOMES WERE REPORTED, AND ARE NOT ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613488 ↗