Neuroguard IEP® System NG-0630-140-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851616007583), received between Dec 4, 2025 and Jul 10, 2026 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785417 ↗
• MalfunctionJan 15, 2026Mechanical Jam

  EVENT DESCRIPTION: A PHYSICIAN WAS ATTEMPTING TO USE A NEUROGUARD DEVICE TO TREAT THE LEFT MID COMMON CAROTID REPORTED TO BE CALCIFIED WITH MINIMAL TORTUOSITY. DURING DEPLOYMENT OF THE NEUROGUARD STENT IEP SYS NG-0740-140-2, THE FILTER DID NOT OPEN FULLY UPON INITIAL DEPLOYMENT. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. AN EMBOLIC PROTECTION DEVICE WAS USED, BUT MODEL IS UNKNOWN. SAME DEVICE USED ONCE FILTER FULLY OPENED ON IT'S OWN. THERE WAS NO HEALTH CONSEQUENCES OR IMPACT TO PATIENT FOR THIS EVENT. INVESTIGATION PRELIMINARY: THE PRELIMINARY INVESTIGATION DETERMINED THAT UNKNOWN SOURCE CAUSED A DEFORMATION OF THE OUTER BODY. THE DEFORMATION IS CONSISTENT WITH HEAT DAMAGE. THIS IS A NEW AND UNIQUE FAILURE MODE. THE FAILURE MODE POTENTIALLY RESULTS IN IMPINGEMENT ON THE MOVEMENT (BOTH DIRECTIONS) OF THE FILTER ACTUATION WIRE. CONCLUSIONS: THE DEFORMATION OF THE OUTER BODY CAUSED ADDITIONAL FRICTION IN THE FILTER WIRE ACTUATION LED TO A SLOW OPENING AND CLOSING FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085773 ↗
• MalfunctionDec 4, 2025Difficult to Insert; Use of Device Problem; Device Damaged by Another Device; Difficult to Insert; Use of Device Problem; Device Damaged by Another Device

  CONTEGO MEDICAL WAS NOTIFIED ON THE EVENT ON NOVEMBER 04, 2025. THIS MDR IS BEING FILED AS A CONSERVATIVE MEASURE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WITHOUT THE RETURNED DEVICE, A PHYSICAL OR FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION WAS THEREFORE BASED ON THE EVENT DESCRIPTION, INFORMATION PROVIDED BY THE SALES REPRESENTATIVE AND ATTENDING PHYSICIAN. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CONSISTENT WITH EXCESSIVE FORCE APPLIED DURING DEVICE ADVANCEMENT AND WITHDRAWAL AFTER RESISTANCE WAS ENCOUNTERED. NO PATIENT HARM WAS REPORTED. BELOW ARE THE DETAILS AS REPORTED. EVENT AS REPORTED. THE NEUROGUARD STENT IEP SYS NG-0630-140-2 DEVICE WAS PREPPED ACCORDING TO IFU BY FELLOW AND ATTENDING. THE FELLOW BEGAN TO ADVANCE THE DELIVERY SYSTEM OVER THE NON-MEDTRONIC (EZ FILTERWIRE) GUIDEWIRE THAT WAS ALREADY IN PLACE THROUGH A 6FR NON-MEDTRONIC (SHUTTLE) SHEATH. HE EXPERIENCED SOME FRICTION AND UNFORTUNATELY KEPT PUSHING. THE ATTENDING THINKS THE TUOHY WAS TOO TIGHT OR THE FELLOW WAS COMPRESSING THE NON-MEDTRONIC SHEATH WHILE ADVANCING THE DELIVERY SYSTEM. THE ATTENDING AND SALES REP SAID TO PAUSE AND IT WAS DISCOVERED THAT THERE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723448 ↗

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