Neuron PNML6F0881004-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948022355), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE C2 SEGMENT OF THE CAROTID ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN USED THE SUPPORT CATHETER TO GUIDE THE NEURON MAX TO THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A STENT. DURING RELEASE OF THE STENT, THE PHYSICIAN VISUALIZED UNDER FLUOROSCOPY THAT THE NEURON MAX WAS FRACTURED AROUND THE DISTAL END. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, A NEW CATHETER, AND THE SAME STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146276 ↗