Neuron PNML6F088904M-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00815948022409), received between Mar 22, 2021 and Jun 2, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A MEDICAL PROCEDURE IN THE VERTEBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE THROUGH THE DISTAL LENGTH OF THE NEURON MAX. AFTER COMPLETING THE PROCEDURE, THE PHYSICIAN RETRACTED THE NEURON MAX OUT OF THE PATIENT AND FOUND THAT IT WAS DAMAGED AT THE DISTAL END. AT THIS POINT, THE PROCEDURE WAS ALREADY COMPLETED AND NO ADDITIONAL DEVICES WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128419 ↗
• InjuryJan 2, 2025Fracture; Migration; Fracture; Migration

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN THE MIDDLE CEREBRAL ARTERY (MCA) SUPERIOR BRANCH USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA SHEATH (8F SHORT SHEATH), A NON-PENUMBRA GUIDE CATHETER, AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE NEURON MAX INTO THE INTERNAL CAROTID ARTERY (ICA) USING THE SHEATH. WHILE ATTEMPTING TO INTRODUCE THE MICROCATHETER TO THE SUPERIOR BRANCH OF THE MCA, THE PHYSICIAN NOTICED CLOT FORMATION. UPON FURTHER INSPECTION, THE PHYSICIAN FOUND THAT THE MARKERBAND OF THE NEURON MAX HAD DISCONNECTED FROM THE TIP AND WAS FOUND IN THE MCA, AND A PIECE OF THE DISTAL END OF THE NEURON MAX HAD DETACHED AND MIGRATED INTO THE MCA. THE PHYSICIAN BELIEVED THAT THE CLOT FORMATION OCCURRED DUE TO THE MARKERBAND DETACHMENT. THE PHYSICIAN DECIDED TO ADMINISTER HEPARIN TO TREAT THE CLOT FORMATION; HOWEVER, IT DID NOT RESOLVE. THE PATIENT THEN EXPERIENCED AN ACUTE STROKE ON THE OPERATING TABLE. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE STROKE WAS CAUSED BY THE DAMAGE TO THE NEURON MAX. THE NEURON MAX, GUIDE CATHETER, AND MICROCATHETER WERE THEN REMOVED

  Patient problems: Stroke/CVA

  MAUDE report 21061309 ↗
• MalfunctionJul 26, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AN ANGIOGRAPHIC CATHETER (5F), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT HAD A TYPE III ARCH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON MAX. THE PHYSICIAN THEN DECIDED TO REMOVE THE NEURON MAX FROM THE PATIENT. AFTER REMOVING THE NEURON MAX, THE PHYSICIAN FOUND THAT IT WAS FRACTURED AT THE DISTAL END. THEREFORE, THE NEURON MAX WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, THE SAME ANGIOGRAPHIC CATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844257 ↗
• MalfunctionJul 12, 2024Fracture; Leak/Splash; Fracture; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A RIGHT CEREBRAL HEMISPHERE OCCLUSION USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). IT SHOULD BE NOTED THAT THE PATIENT HAD A TYPE III ARCH, AND THE RIGHT INTERNAL CAROTID ARTERY (ICA) C1 SEGMENT WAS STENOSED AND NOTABLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE60 AND ADVANCED THE NEURON MAX PAST THE STENOSIS IN THE C1 SEGMENT TO PROVIDE MORE SUPPORT TO THE ACE60. SUBSEQUENTLY, THE PHYSICIAN VISUALIZED FLUID LEAKING DURING CONTINUOUS ROTATION OF THE PROXIMAL END OF THE NEURON MAX. THE PHYSICIAN THEN DECIDED TO REMOVE THE NEURON MAX. AFTER REMOVING THE NEURON MAX FROM THE PATIENT, THE PHYSICIAN CUT THE YELLOW COATING OF THE NEURON MAX AND FOUND THAT THE NEURON MAX WAS FRACTURED AT THE PROXIMAL END NEAR THE HUB AND WAS CAUSING FLUID LEAKAGE. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, THE SAME ACE60, A NON-PENUMBRA CATHETER TO NAVIGATE BEYOND THE C1 SEGMENT, AND A GUIDEWIRE TO NAVIGATE BEYOND THE STENOSED C1 SEGMENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735503 ↗
• MalfunctionDec 18, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 6F (6F SELECT), PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA SHORT SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHORT SHEATH AND THE NEURON MAX IN THE PATIENT. WHILE ATTEMPTING TO ADVANCE THE 6F SELECT THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE 6F SELECT FURTHER. WHILE ATTEMPTING TO RETRACT THE 6F SELECT, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE 6F SELECT BECAME STUCK WITHIN THE NEURON MAX. THEREFORE, THE 6F SELECT AND NEURON MAX WERE REMOVED TOGETHER. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE NEURON MAX WAS FRACTURED. THEREFORE, THE PHYSICIAN USED THE RED62 TO ASPIRATE THE DISTAL END SEGMENT OF THE NEURON MAX. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, A NEW 6F SELECT AND THE SAME PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347957 ↗
• MalfunctionJul 5, 2023Break; Material Puncture/Hole; Material Deformation; Break; Material Puncture/Hole; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN FRACTURED THE NEURON MAX IN THE PATIENT. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263473 ↗
• MalfunctionDec 23, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE USING THE NEURON MAX THE PHYSICIAN PERFORMED A CONTRAST RUN AND NOTICED THAT THE NEURON MAX WAS FRACTURED. THEREFORE, THE NEURON MAX WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082730 ↗
• MalfunctionMar 22, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, AFTER THE PHYSICIAN ADVANCED A NEURON MAX INTO THE PATIENT, IT WAS NOTED THAT THE HEMOSTASIS VALVE ADAPTER (HVA) WOULD NOT CONNECT TO THE HUB OF THE NEURON MAX. THEREFORE, THE HVA WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA VALVE AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547732 ↗