Neuron PNML6F088904-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00815948022393), received between Aug 7, 2020 and Apr 18, 2025 — classified as 1 death, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathApr 18, 2025Material Fragmentation; Material Fragmentation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WITH SOME DIFFICULTY, THE NEURON MAX WAS ADVANCED THROUGH A STENT AT THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. UPON REMOVAL OF THE NEURON MAX 6F SELECT INNER CATHETER, THE NEURON MAX DISTAL TIP WAS FOUND TO BE FRACTURED. CONTRAST INJECTION DEMONSTRATED MINIMAL FLOW INTO THE LEFT MIDDLE CEREBRAL ARTERY AS WELL AS THE LEFT ANTERIOR CEREBRAL ARTERY DUE TO THE FRACTURED NEURON MAX SEGMENT. ATTEMPTS TO RETRIEVE THE NEURON MAX FRACTURED SEGMENT WERE UNSUCCESSFUL FOLLOWED BY GROSS SUBARACHNOID HEMORRHAGE. SUBSEQUENT COIL OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY WAS PERFORMED TO CONTROL BLEEDING. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. POST-PROCEDURE, THE PATIENT REMAINED INTUBATED, NOT SEDATED, REQUIRING FOUR VASOPRESSORS. THE PATIENT HAD NO COUGH, GAG, OR CORNEAL REFLEX. PUPILS WERE 7MM AND NONREACTIVE BILATERALLY. DISCUSSION WITH THE SPOUSE/FAMILY GIVEN HEMODYNAMIC INSTABILITY AND UNLIKELY MEANINGFUL OUTCOME. THE FAMILY DECIDED TO TRANSITION TO COMFORT CARE, AND THE PATIENT EXPIRED ON (B)(6) 2025.

  Patient problems: Brain Injury; Foreign Body Embolism; Intracranial Hemorrhage

  MAUDE report 21869144 ↗
• MalfunctionFeb 5, 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). DURING THE PROCEDURE, WHILE ADVANCING THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE NEURON MAX WAS FRACTURED BUT STILL CONNECTED BY ITS INNER WIRE. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640302 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER COMPLETING MULTIPLE PASSES USING THE NEURON MAX, THE PHYSICIAN FRACTURED THE NEURON MAX AT THE PROXIMAL END NEAR THE HUB. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954711 ↗
• InjuryMay 27, 2022Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA STENT RETRIEVER, A PENUMBRA SELECT CATHETER, A NON-PENUMBRA SHEATH, AND TWO GUIDEWIRES. IT WAS REPORTED THAT THERE WAS A SMALL DISSECTION IN THE INTERNAL CAROTID ARTERY (ICA) PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS IN THE FEMORAL ARTERY USING THE 8F SHEATH. THEN, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE LEFT INTERNAL CAROTID ARTERY (ICA) USING THE SELECT CATHETER AND GUIDEWIRE. NEXT, THE PHYSICIAN ADVANCED THE RED72 OVER THE VELOCITY, AND GUIDEWIRE THROUGH THE NEURON MAX TO THE CLOT IN THE TARGET VESSEL. NEXT, THE PHYSICIAN REMOVED THE GUIDEWIRE AND ADVANCED THE STENT RETRIEVER DEVICE THROUGH THE VELOCITY AND INTO THE TARGET VESSEL. AFTER REMOVING THE VELOCITY, THE PHYSICIAN INITIATED ASPIRATION AND SUCCESSFULLY COMPLETED ONE PASS USING THE RED72 AND STENT RETRIEVER DEVICE. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE RED72 AND STENT RETRIEVER DEVICE. THE PHYSICIAN THEN COMPLETED ANOTHER PASS U

  Patient problems: Vascular Dissection

  MAUDE report 14527252 ↗
• MalfunctionOct 18, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON SELECT CATHETER 6F (6F SELECT), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE NEURON MAX AND 6F SELECT TO GAIN ACCESS TO THE TARGET VESSEL. UPON REMOVAL OF THE 6F SELECT, THE PHYSICIAN KINKED THE NEURON MAX NEAR THE HUB. THEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED72 THROUGH THE NEURON MAX; HOWEVER, THE RED72 WOULD NOT ADVANCE. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ONE PASS USING THE SAME RED72, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND A BMX96 ACCESS SYSTEM (BENCHMARK MAX). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651681 ↗
• MalfunctionSep 14, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE DISTAL END OF THE JET7 BROKE INSIDE THE PATIENT'S BODY. IT WAS REPORTED THAT THE NEURON MAX USED WITH THE JET7 WAS KINKED WHICH MAY HAVE CAUSED DAMAGE TO THE JET7. THE PHYSICIAN WAS ABLE TO RETRIEVE ALL THE PIECES OF THE JET7 FROM THE PATIENT'S BODY. 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 12469121 ↗
• MalfunctionJul 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE ACE68 THROUGH THE DISTAL END OF THE NEURON MAX. THEREFORE, THE ACE68 WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW ACE68 THROUGH THE NEURON MAX; HOWEVER THE SAME ISSUE OCCURRED. THEREFORE, THE ACE68 AND NEURON MAX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132111 ↗
• MalfunctionJun 3, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA SHORT SHEATH AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, WHILE ADVANCING A 5F SELECT HALFWAY THROUGH A SHORT SHEATH, THE 5F SELECT BECAME STUCK AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE 5F SELECT AND THE SHORT SHEATH WERE REMOVED. NEXT, WHILE ADVANCING A NEURON MAX HALFWAY THROUGH A LONG SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE NEURON MAX BECAME STUCK AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE NEURON MAX WAS REMOVED. AFTERWARDS, THE PHYSICIAN PERFORMED ANOTHER DIAGNOSTIC TEST AND DECIDED THAT THE PATIENT DID NOT NEED INTERVENTION. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932633 ↗
• MalfunctionMay 18, 2021Material Twisted/Bent

  PENUMBRA NEURON SHEATH WAS BENT AND UNABLE TO USE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11847882 ↗
• MalfunctionMay 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING A JETD AND A NEURON MAX. UPON ATTEMPTING TO REMOVE THE JETD, THE PHYSICIAN NOTICED THAT THE JETD WAS STUCK INSIDE THE NEURON MAX. THEREFORE, THE PHYSICIAN REMOVED THE JETD AND NEURON MAX TOGETHER. AFTERWARDS ON THE BACK TABLE, THE PHYSICIAN ATTEMPTED TO REMOVE THE JETD FROM THE NEURON MAX FORCEFULLY BUT WAS UNSUCCESSFUL. CONSEQUENTLY, THE JETD BECAME STRETCHED DURING THE ATTEMPT TO REMOVE IT FROM THE NEURON MAX. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795377 ↗
• MalfunctionApr 25, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VENOUS SINUS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, WHILE LOADING THE NEURON MAX INTO THE SHORT SHEATH, THE NEURON MAX BROKE AT THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME SHORT SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722084 ↗
• MalfunctionApr 20, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A NEURON SELECT CATHETER 5F(5F SELECT). DURING THE PROCEDURE, WHEN ATTEMPTING TO TORQUE THE NEURON MAX IN THE COMMON CAROTID, THE NEURON MAX BECAME KINKED AT THE MIDDLE TO DISTAL SHAFT. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SHEATH WITH THE SAME 5F SELECT AND VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697507 ↗
• MalfunctionApr 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE THE FIRST PASS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE NON-PENUMBRA CATHETER THROUGH THE NEURON MAX. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649248 ↗
• MalfunctionFeb 12, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEREBRAL ARTERY USING A NEURON (B)(4) LONG SHEATH (NEURON MAX) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, THE HUB OF THE NEURON MAX BROKE OFF WHILE THE DEVICE WAS BEING TORQUED AROUND A TURN IN THE VASCULATURE. THEREFORE, THE 5F SELECT AND THE NEURON MAX WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA SHEATH AND THE SAME 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11325176 ↗
• MalfunctionDec 9, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE JET7 AND NEURON MAX. WHILE REMOVING THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE DUE TO THE PATIENT'S ANATOMY; THEREFORE, THE PHYSICIAN PULLED BOTH NEURON MAX AND JET7 SLIGHTLY TO ELIMINATE ANY TENSION IN THE SYSTEM. AFTER THIS, THE JET7 WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL TIP OF THE JET7 HAD BROKEN OFF. THEREFORE, THE PHYSICIAN OBTAINED LEFT FEMORAL ACCESS IN ANTICIPATION OF NEEDING TO SNARE. HOWEVER, UPON REMOVAL OF THE NEURON MAX, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE JET7 WAS LODGED IN THE NEURON MAX. THE PROCEDURE ENDED AT THIS POINT AND THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 RECANALIZATION WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10980247 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SYSTEM JET 7 REPERFUSION CATHETERS (JET7)S AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE JET7 WAS LEAKING JUST BEYOND THE HUB ON THE BACK TABLE. THEREFORE, THE JET7 WAS NOT USED IN THE PROCEDURE. ANOTHER JET7 WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS ALSO REPORTED THAT WHILE THE NEURON MAX WAS STILL INSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS KINKED; THE NEURON MAX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10847303 ↗
• MalfunctionAug 7, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). IT WAS NOTED THAT THE PATIENT HAD TYPE III ARCH AND AN ANATOMY THAT WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX UNTIL IT WAS UNABLE TO BE ADVANCED BEYOND THE CAROTID BIFURCATION. IT WAS NOTED THAT THE TAKEOFF OF THE BRACHIOCEPHALIC ARTERY WAS VERY TORTUOUS. THE PHYSICIAN THEN ADVANCED THE VELOCITY OVER THE JET7 BEYOND THE BRACHIOCEPHALIC ARTERY; BUT EVENTUALLY WAS UNABLE TO ADVANCE THEM ANY FURTHER. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE THE VELOCITY AND JET7 FURTHER BUT WERE UNSUCCESSFUL. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO RETRACT THE VELOCITY AND JET7. UPON REMOVAL, IT WAS NOTICED THAT THE JET7 STRETCHED AND THE DISTAL TIP HAD BROKEN OFF. THE PHYSICIAN CONFIRMED THAT THE BROKEN PIECE OF THE JET7 WAS LODGED WITHIN THE DISTAL END OF THE NEURON MAX; THEREFORE, THE NEURON MAX CONTAINING THE BROKEN PIECE OF THE JET7 WAS REMOVED. UPON REMOVAL IT WAS NOTICED THAT THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381151 ↗