Neuron PNS5F120SIMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548010205), received between Sep 17, 2018 and Aug 27, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K083125); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATHETER THROUGH THE ANATOMY AND REPORTED THAT IT BECAME CRACKED AT THE HUB. THE 5F SELECT WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935977 ↗
• InjuryDec 14, 2018Break; Fracture; Break; Fracture

  THE PATIENT WAS UNDERGOING A DIAGNOSTIC PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT) THROUGH A 5F SHEATH VIA RADIAL APPROACH. DURING THE PROCEDURE, THE 5F SELECT FRACTURED INSIDE THE PATIENT. THE PROXIMAL END OF THE FRACTURED SEGMENT WAS SNARED AND SUCCESSFULLY REMOVED FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166541 ↗
• MalfunctionSep 17, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE NEURON SELECT CATHETER 5F (5F SELECT) FELL APART WHILE BEING ADVANCE OVER THE WIRE. THE DAMAGE TO THE 5F SELECT OCCURRED PRIOR TO BEING INSERTED INTO THE PATIENT¿S BODY; THEREFORE, THE 5F SELECT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 7881825 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083125. One submission often covers many models, so check the product and lot details in each record.

• Z-2049-2009 · Jul 2, 2009 · Terminated
  Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional