Neuron PNML6F0881004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548012292), received between Nov 2, 2018 and Jul 25, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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.

• DeathJul 25, 2019Physical Resistance/Sticking; 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 JET7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE JET7 AND VELOCITY THROUGH THE NEURON MAX. AFTER COMPLETING TWO PASSES, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING AND RETRACTING THE JET7 AND SUBSEQUENTLY THE JET7 FRACTURED. THE NEURON MAX CONTAINING THE BROKEN JET7 WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE NEURON MAX, A KINK WAS OBSERVED. THE PROCEDURE WAS CONCLUDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT THEN LATER EXPIRED; HOWEVER, THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 8829330 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM IN THE LEFT MIDDLE CEREBRAL ARTERY. THEREFORE, THE PHYSICIAN ADMINISTERED 5MG OF VERAPAMIL TO TREAT THE VASOSPASM. A FOLLOW-UP ANGIOGRAPHY WAS PERFORMED AFTER 5 MINUTES WHICH SHOWED WORSENING VASOSPASM; THEREFORE, THE PHYSICIAN ADMINISTERED ANOTHER 5MG OF VERAPAMIL. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY (B)(6) 2019. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH PROBABLE RELATIONSHIP TO THE NEURON MAX, POSSIBLE RELATIONSHIP TO THE JET7 AND DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 8824165 ↗
• MalfunctionNov 2, 2018Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A NEURON 6F SELECT CATHETER (6F SELECT) WOULD NOT ADVANCE ALL THE WAY THROUGH THE DISTAL TIP OF A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) ON THE BACK TABLE; THEREFORE, BOTH NEURON MAX AND 6F SELECT WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND 6F SELECT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035661 ↗