Neuroguard IEP SystemRecalls & reported problems across all models

We found 8 models of Neuroguard IEP System by Contego Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2025 and Sep 18, 2026 — classified as 7 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (32 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Neuroguard IEP System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 29, 2026Open, 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 · names 8 of these models · Recall details · FDA record ↗

2. Sep 4, 2025Open, 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 · names 4 of these models · Recall details · FDA record ↗

Most reported Neuroguard IEP System problems

Neuroguard IEP System models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Neuroguard IEP® System NG-0740-140-2

  Stent, Carotid
  2 recalls32 reports
• Neuroguard IEP® System NG-NV-6-40

  Stent, Carotid
  2 recalls9 reports
• Neuroguard IEP® System NG-NV-7-40

  Stent, Carotid
  2 recalls8 reports
• Neuroguard IEP® System NG-0640-140-2

  Stent, Carotid
  2 recalls7 reports
• Neuroguard IEP® System NG-0730-140-2

  Stent, Carotid
  1 recall5 reports
• Neuroguard IEP® System NG-0630-140-2

  Stent, Carotid
  1 recall3 reports
• Neuroguard IEP® System NG-NV-6-30

  Stent, Carotid
  1 recall2 reports
• Neuroguard IEP® System NG-NV-7-30

  Stent, Carotid
  1 recall1 report

Recent Neuroguard IEP System adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 30, 2026Activation Failure; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50512696 ↗
• InjuryAug 23, 2026Premature Activation; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation

  During the same procedure, two Neuroguard devices malfunctioned. A separate Medical Device Report is being made for each device. This report is for the second one. See report 3011471056-2026-00060 for the first. It was further reported that a second device (NG-NV-6-30 Neuroguard Stent IEP System) was attempted through the same 7Fr non-Contego catheter as the first device and the same resistance and inability to advance occurred, with the system not advancing past the distal end of the 7F catheter. The resistance was reported to have caused the system wire to buckle through the sheath retraction deployment knob. Resistance in the catheter caused an unsheathe and stent deployment inside the guide catheter. Both the 7Fr non-Contego catheter and Neuroguard were again successfully removed together without patient harm. A 6Fr non-Contego (Penumbra Benchmark) catheter and a 7x30 non-Contego (Cordis Precise Pro RX) stent were used to complete the procedure without issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50396436 ↗
• MalfunctionAug 3, 2026Break; Activation Failure; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111153 ↗
• MalfunctionAug 3, 2026Break; Activation Failure; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111150 ↗
• MalfunctionJul 16, 2026Entrapment of Device; Malposition of Device; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849530 ↗
• MalfunctionJul 14, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25819104 ↗
• 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 25785522 ↗