Neuron PND6F10512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548010083), received between Jan 8, 2016 and Feb 27, 2018 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K082290); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THAT A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) WAS KINKED ON THE BACK TABLE. THE DAMAGED NEURON 053 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7299059 ↗
• MalfunctionJan 8, 2016Break; Detachment Of Device Component; Failure to Advance; Break; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A NEUROFISTULA EMBOLIZATION PROCEDURE IN THE CEREBRAL VENOUS USING A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, AFTER AN UNSUCCESSFUL ATTEMPT TO ADVANCE THE NEURON 053 THROUGH THE TRANSVERSE SINUS, IT WAS WITHDRAWN OVER THE VELOCITY. WHILE WITHDRAWING THE NEURON 053 FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE MARKER BAND DID NOT MOVE. THE PHYSICIAN THEN REMOVED THE VELOCITY AND NOTICED THAT THE VELOCITY'S MARKER BAND WAS NOT MOVING. UPON INSPECTION OF BOTH THE NEURON 053 AND VELOCITY, IT WAS OBSERVED THAT THE MARKER BANDS BROKE OFF OF THE CATHETERS. THE MARKER BAND OF THE NEURON 053 WAS LEFT IN THE TRANSVERSE SINUS AND THE MARKER BAND OF THE VELOCITY WAS LEFT IN THE SUPERIOR SAGITTAL SINUS. THERE WERE NO ATTEMPTS MADE TO RETRIEVE THE MARKER BANDS BECAUSE THE PHYSICIAN FELT THAT IT MAY CAUSE MORE HARM TO THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY ADVANCING A NEURON 088 MAX LONG SHEATH TO THE SIGMOID SINUS AND ANOTHER MANUFACTURER'S MICROCATHETER THROUGH THE PATIENT'S ANATOMY TO THE DESIRED LOCATION FOR TREATMENT. AS OF 12/18/2015, THE PATIENT IS RECOVERING FINE FROM A

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5354045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082290. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2010 · Sep 22, 2009 · Terminated
  Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda,