Neuron PNML6F0881004MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548012285), received between Jun 18, 2020 and Jun 20, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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

• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, A NON-PENUMBRA WALL STENT, AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 OVER THE VELOCITY AND GUIDEWIRE THROUGH THE SHEATH TO THE TARGET LOCATION. NEXT, THE VELOCITY WAS RETRACTED AND UPON REMOVAL, THE MID-SHAFT OF THE VELOCITY WAS NOTICED TO BE FRACTURED. THE VELOCITY WAS REMOVED IN ITS ENTIRETY AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN PERFORMED A CRANIAL ANGIOGRAPHY AND NOTICED THE CLOT MIGRATED FROM THE M1 SEGMENT TO THE RIGHT M2 SEGMENT. AFTER THE ANGIOGRAPHY WAS PERFORMED, A NEW VELOCITY ALONG WITH THE RED72 AND GUIDEWIRE WERE ADVANCED TO THE M2 SEGMENT. THE VELOCITY AND GUIDEWIRE WERE THEN REMOVED AND THE RED72 WAS USED TO ASPIRATE TO COMPLETE THE FIRST PASS. A CERVICAL ANGIOGRAPHY REVEALED DISSECTION OF THE CERVICAL SEGMENT OF THE ICA. NEXT, A GUIDEWIRE WAS ADVANCED ACROSS THE CERVICAL DISSECTION AND INTO THE VESSEL. T

  Patient problems: Vascular Dissection

  MAUDE report 17167188 ↗
• MalfunctionOct 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA INTERMEDIATE CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE SUCCESSFULLY PLACING THE NEURON MAX INTO THE PATIENT. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE INTERMEDIATE CATHETER THROUGH THE NEURON MAX. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME INTERMEDIATE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619404 ↗
• MalfunctionJun 18, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE NEURON MAX INTO THE PATIENT, THE NEURON MAX KINKED; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 10172274 ↗