Neuroguard IEP® System NG-0730-140-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851616007606), received between Mar 6, 2026 and Jul 10, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Activation Problem

  IT WAS REPORTED THAT A NEUROGUARD STENT IEP SYSTEM WAS BEING PREPARED FOR USE FOR A RIGHT PROXIMAL INTERNAL CAROTID ARTERY PROCEDURE WHEN THE FILTER WHEEL WOULD NOT OPEN THE FILTER DURING PREPARATION. IT JUST SPUN FREELY BACK AND FORTH. IT IS SUSPECTED THAT THE INTERNAL WIRE WELD BROKE OFF. THE INSTRUCTIONS FOR USE WERE REPORTED TO HAVE BEEN FOLLOWED WITH THE STYLET PUT BACK IN AS WELL. THE DEVICE WAS NOT USED IN A PATIENT AND WAS NEVER IMPLANTED. A 6FR NON-MEDTRONIC (COOK SHUTTLE) SHEATH WAS INTENDED TO BE USED. THE PROCEDURE WAS COMPLETED USING A NEW NEUROGUARD 9/7/8X40 DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25784049 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782657 ↗
• MalfunctionJun 5, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE NEUROGUARD WAS PREPPED ACCORDING TO THE IFU WITH NO ISSUE. DEVICE WAS POSITIONED WITHIN THE LESION FOR TREATMENT. THE TARGET VESSEL WAS THE LICA/LCCA. BLUE OUTER SHEATH WAS RETRACTED TO EXPOSE THE NG [NEUROGUARD] FILTER, FILTER DEPLOYMENT KNOB WAS TURNED COUNTERCLOCKWISE ACCORDING TO THE IFU, BUT THE FILTER WAS INITIALLY UNRESPONSIVE OPENING. THE SIX FILTER MARKERS WERE VISUALIZED OPENING COMPLETELY AS THE BLUE SHEATH WAS RETRACTING BACK DEPLOYING THE SHEATH. STENT WAS DEPLOYED AND THE CASE WAS COMPLETED. UPON VISUAL INSPECTION FOR DEBRIS IN THE FILTER ON THE BACK TABLE POST PROCEDURE, THE FILTER WAS UNRESPONSIVE TO OPENING USING THE FILTER DEPLOYMENT KNOB. THE PROCEDURE WAS COMPLETED WITH NO INCIDENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414379 ↗
• MalfunctionApr 2, 2026Component or Accessory Incompatibility

  EVENT DESCRIPTION REMOVAL DIFFICULTIES. NEUROGUARD (STENT DELIVERY CATHETER, AS THE STENT WAS SUCCESSFULLY DEPLOYED, AND THE DIFFICULTIES WERE UPON DELIVERY CATHETER REMOVAL) WOULD NOT COME OUT OF CO-PILOT, DOCTOR REMOVED CO-PILOT WITH DEVICE LEAVING WIRE IN AND REATTACHING CO-PILOT. PROCEDURE WENT GOOD TILL REMOVING NEUROGUARD FROM SHEATH/ CO-PILOT. THE DEVICE WAS PULLING OUT LIKE NORMAL TILL NEAR THE RAPID EXCHANGE WIRE PORT. THE CO-PILOT WAS HELD WIDE OPEN, BUT THE NEUROGUARD WOULD NOT COME OUT. THE PHYSICIAN HAD TO REMOVE THE CO-PILOT FROM THE SHEATH AND REMOVE THE NEUROGUARD OVER THE WIRE AND REPLACE THE CO-PILOT ONTO THE SHEATH OVER THE WIRE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED AFTER REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION: DEVICE DISCARDED, NO INVESTIGATION DEVICE POSSIBLE. PER THE IFU, THE NEUROGUARD SHOULD BE USED WITH A ROTATING HEMOSTATIC VALVE. (THE CO PILOT MANUFACTURED BY ABBOTT VASCULAR, IS NOT A ROTATING HEMOSTATIC VALVE, INSTEAD IS A SPRING LOADED COMPRESSION HEMOSTATIC VALVE.) SUSPECTED PRIMARY CAUSE: THE MOST PROBABLE CONTRIBUTING FACTOR IS THE USE OF A CO-PILOT HEMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772657 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: A PHYSICIAN USED A NEUROGUARD STENT IEP SYSTEM FOR PATIENT TREATMENT. THE TREATED SEGMENT WASN'T OVERLY CALCIFIC. THE COMMON CAROTID ARTERY (CCA) INTO INTERNAL CAROTID ARTERY (ICA) WAS STRAIGHT. THE DISTAL ICA DID HAVE A LOOP. A 5 MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS IN PLACE RIGHT BEFORE THE ICA LOOPED. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). A 7FR NON-MEDTRONIC (TERUMO) SHEATH WAS USED. THERE WERE NO OTHER DEVICES USED. THE PROCEDURE WENT WELL, EVERYONE WAS HAPPY, PATIENT WAS GOOD. HOWEVER, THE PATIENT HAD AN EMBOLIC STROKE 10 HOURS POST PROCEDURE AND FULLY RECOVERED THE FOLLOWING DAY. PHYSICIAN SAID THE STENT AND VESSEL LOOK FINE, AND HE IS NOT SURE WHERE THE EMBOLIC EVENT CAME FROM. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT. INVESTIGATION: ON 12FEB2026, ADDITIONAL INFORMATION FROM DR. (B)(6): DR. (B)(6) SPOKE WITH THE PHYSICIAN (SUMMARY). FURTHER INFORMATION OBTAINED FROM THE PHYSICIAN: PATIENT WAS AN ASYMPTOMATIC 70-YEAR-OLD MALE. ASHD W STENTS. PAD W STENTS. ATRIAL FIB (ELIQUIS APPROPRIATELY HELD). REMOTE STROKE FROM AFIB. PROGRESSIVE CAROTID ARTERY STENOSIS ON LICA. THE CAROTID STENT PROCEDURE "WENT VERY WELL". BRADYCARDIA

  Patient problems: Bradycardia; Dysphasia; Ischemia Stroke; Muscle Weakness/Atrophy; Transient Ischemic Attack

  MAUDE report 24536672 ↗

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