Neuron PNS5F130H1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548010229), received between Jun 22, 2017 and Jun 19, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLANNED TO PERFORM A DIAGNOSTIC ANGIOGRAM UNDER GENERAL ANESTHESIA. WHILE ATTEMPTING TO ADVANCE THE 5F SELECT OVER THE GUIDEWIRE IN THE RIGHT COMMON CAROTID ARTERY (CCA), THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE DISTAL END WAS UNRESPONSIVE INDICATING A FRACTURE. THE PHYSICIAN THEN USED A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT. WHILE RETRACTING IT THROUGH THE AORTA, THE FRACTURED SEGMENT COULD NOT BE STABILIZED WITHIN THE GUIDE CATHETER AND MIGRATED INTO THE LEFT EXTERNAL ILIAC ARTERY. IT WAS THEN RETRIEVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288890 ↗
• MalfunctionMay 10, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE CAROTID ARTERY USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A STENT (UNKNOWN). DURING THE PROCEDURE, THE 5F SELECT WAS ADVANCED FROM THE RADIAL ARTERY TO THE TARGET VESSEL. THE PHYSICIAN TORQUED THE 5F SELECT AND NOTICED UNDER FLUOROSCOPY THAT THE 5F SELECT FRACTURED. THE FRACTURED DISTAL SEGMENT OF THE 5F SELECT WAS SUCCESSFULLY SNARED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON-PENUMBRA CATHETER (UNKNOWN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PATIENT WAS LATER DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288269 ↗
• InjuryJan 17, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID ARTERY USING NEURON SELECT CATHETERS 5F (5F SELECTS). DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT IN THE COMMON CAROTID ARTERY, THE TIP OF THE 5F SELECT DETACHED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED TIP. IT WAS REPORTED THAT IT TOOK APPROXIMATELY TWO HOURS TO RETRIEVE THE DETACHED TIP. THE PHYSICIAN THEN CONTINUED THE PROCEDURE USING A NEW 5F SELECT; HOWEVER, THE 5F SELECT BROKE, AND WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602906 ↗
• InjuryJun 22, 2017Break; Fracture; Break; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CAROTID ARTERY USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT WITHIN THE PATIENT TO GUIDE THE NEURON MAX TO THE TARGET LOCATION IN THE HIGH CERVICAL ARTERY, THE DISTAL TIP OF THE 5F SELECT BROKE WITHIN THE AORTA ARTERY. THE PHYSICIAN WANTED TO TAKE CARE OF THE STROKE FIRST, SO HE USED A REPERFUSION CATHETER AND MICROCATHETER WITH THE SAME NEURON MAX TO REMOVE THE THROMBUS. THE BROKEN 5F SELECT TIP WAS THEN REMOVED FROM THE PATIENT USING A SNARE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6662375 ↗

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