Neuron PNS5F130SIM-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948027886), received between May 13, 2025 and Aug 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162832 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT COMMON CAROTID ARTERY (CCA) USING BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARKS), A NEURON SELECT CATHETER 5F (5F SELECT), AND A RADIAL INTRODUCER SHEATH. DURING THE PROCEDURE, THE PHYSICIAN USED THE 5F SELECT TO GUIDE THE BENCHMARK INTO THE TARGET VESSEL VIA RADIAL APPROACH. WHILE ATTEMPTING TO RETRACT THE 5F SELECT, THE PHYSICIAN NOTICED THAT THE 5F SELECT WAS NOT RESPONDING TO MOVEMENTS AND DECIDED TO REMOVE IT. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL LENGTH OF THE 5F SELECT WAS FRACTURED INSIDE THE BENCHMARK. THE BENCHMARK WAS THEN REMOVED WITH THE FRACTURED SEGMENT OF 5F SELECT. THE BENCHMARK WAS FOUND TO BE KINKED AT THE DISTAL LENGTH AFTER REMOVAL. THE PHYSICIAN THEN OPENED A NEW BENCHMARK AND FOUND THAT IT WAS LEAKING AT THE PROXIMAL LENGTH WHILE FLUSHING THE BENCHMARK BEFORE INSERTION INTO THE PATIENT. THEREFORE, THE BENCHMARK WAS NOT USED WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME RADIAL INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010980 ↗

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