Neuroguard IEP® System NG-0640-140-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00851616007590), received between Jun 13, 2025 and Sep 18, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831263 ↗
• MalfunctionAug 3, 2026Break; Activation Failure; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111150 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783790 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782683 ↗
• InjuryJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT A NEUROGUARD STENT IEP SYSTEM WAS USED TO TREAT A LEFT PROXIMAL AND DISTAL COMMON CAROTID ARTERY AND INTERNAL CAROTID ARTERY FIBROUS LESION WITH 85-90% STENOSIS, AN APPROXIMATE LENGTH OF 20MM, AND MINIMAL VESSEL TORTUOSITY. COMMON CAROTID ARTERY DIAMETER REPORTED AS 7-7.3MM, AND THE INTERNAL CAROTID ARTERY DIAMETER REPORTED AS 4.5- 5.2MM. A 6 FR NON-MEDTRONIC (COOK SHUTTLE) SHEATH, AND A 6MM 0.014 SPIDER FX EMBOLIC PROTECTION/GUIDEWIRE WERE USED. PRIOR TO PROCEDURE, STAFF WAS INSERVICED AND QUESTIONS/CONCERNS ADDRESSED. THE VESSEL WAS PRE-DILATED WITH A 3MM X 20MM NON-MEDTRONIC (BOSTON SCI EMERGE) BALLOON CATHETER, AND POST-DILATATION WITH THE NEUROGUARD INTEGRATED BALLOON SYSTEM. DURING THE PROCEDURE, THE NEUROGUARD WAS PREPPED, AND DEPLOYED PER INSTRUCTIONS FOR USE (IFU). DURING POST-DILATATION WITH THE NEUROGUARD SYSTEM, THE PATIENT EXPERIENCED A SIGNIFICANT BARORECEPTOR RESPONSE AND EMERGENCY INTERVENTION FROM TEAM WAS REQUIRED TO STABILIZE THE PATIENT. SIMULTANEOUSLY, THE REP OBSERVED THAT THE PHYSICIAN WAS GOING TO MANIPULATE THE DEVICE AND ADVISED HER TO STOP BECAUSE THE SECONDARY FILTER WAS STILL OPEN, SHE WAS ADVISED TO CLOSE THE FILTER BEFORE ANY MANI

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 25402422 ↗
• MalfunctionMar 30, 2026Use of Device Problem; Device Damaged by Another Device; Activation Problem

  VENT DESCRIPTION: A PHYSICIAN USED A NG-0640-140-2 NEUROGUARD STENT IEP SYSTEM FOR THE TREATMENT OF A PLAQUE LESION IN THE PATIENT'S DISTAL LEFT COMMON CAROTID ARTERY. MINIMAL VESSEL TORTUOSITY AND CALCIFICATION WERE REPORTED. A 90CM 6FR NON-MEDTRONIC (FLEXOR CHECKFLOW) SHEATH AND A SPIDER FX GUIDEWIRE/EMBOLIC PROTECTION DEVICE WERE USED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE INTEGRATED DISTAL EMBOLIC PROTECTION FILTER WOULD NOT OPEN ONCE THE SYSTEM WAS INSERTED IN THE BODY. THE FILTER WAS WORKING DURING PREP OF THE DEVICE BUT FAILED TO OPEN ONCE INSERTED ACROSS LESION. THE PHYSICIAN DEPLOYED STENT WITHOUT INTEGRATED EMBOLIC FILTER OPEN. POST-DILATATION WAS PERFORMED WITH THE BALLOON MOUNTED ON NEUROGUARD SYSTEM AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE STENT REMAINS IMPLANTED IN PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION: THE ACTIVATION WIRE SEPARATED FROM THE DISTAL COLLAR. THE INVESTIGATION WAS UNABLE TO DETERMINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719206 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SCHEDULED FOR CAROTID ARTERY REVASCULARIZATION WITH CAROTID STENTING. THE TARGET INTERNAL CAROTID ARTERY WAS DESCRIBED AS AN ASYMPTOMATIC HIGH-GRADE STENOSIS IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. FOLLOWING PRE-DILATION OF THE LESION IN THE RIGHT CAROTID, THE PATIENT BECAME SYMPTOMATIC WITH APHASIA AND RIGHT HEMISPHERIC SYMPTOMS. (THIS IS PRIOR TO THE USE OF THE CONTEGO NEUROGUARD DEVICE). THE PHYSICIAN THEN CONTINUED THE PROCEDURE AND INSERTED THE NEUROGUARD IEP SYSTEM. THE PHYSICIAN NOTED THERE WERE NO ISSUES WITH THE NEUROGUARD SYSTEM. THE NEUROGUARD STENT WAS DEPLOYED AND THEN POST-DILATED WITH THE INTEGRATED ANGIOPLASTY BALLOON. FOLLOWING POST-DILATION, THE NEUROGUARD STENT DELIVERY SYSTEM WAS REMOVED. FOLLOWING REMOVAL OF THE NEUROGUARD SYSTEM, THE PHYSICIAN RE-EVALUATED THE PATIENT WHO STILL HAD NEUROLOGICAL SYMPTOMS. THE STROKE TEAM WAS CALLED AND PROMPTLY CAME TO CATH LAB. TNK WAS ADMINISTERED. THE PATIENT WAS TAKEN EMERGENTLY TO CT. CT REVEALED NO EVIDENCE OF BLEEDING OR STROKE, AND NO FILLING DEFECT. NEUROINTERVENTIONAL RADIOLOGY WAS CONSULTED/READ THE CT, WHO DETERMINED BASED ON THE RESULTS OF THE CT SCAN, NO INTERVENTION WAS REQUIRED. THERE WAS

  Patient problems: Ischemia

  MAUDE report 22205289 ↗