Neuron PNS5F120BERRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814548010182), received between Oct 12, 2016 and Mar 21, 2024 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT, WAS UNDERGOING A THROMBECTOMY PROCEDURE. TO TREAT A TOTAL CAROTID ARTERY OCCLUSION USING A NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND GUIDEWIRE. IT WAS NOTED, THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 5F SELECT THROUGH THE CAROTID ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE DISTAL LENGTH OF THE 5F SELECT. THE PROCEDURE WAS ENDED AT THIS POINT. THE PATIENT WAS THEN TAKEN TO SURGERY AND THE FRACTURED SEGMENT OF THE 5F SELECT WAS REMOVED SUCCESSFULLY. THE PATIENT, THEN EXPIRED THE NEXT DAY, DUE TO THE TOTAL CAROTID ARTERY OCCLUSION.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 18956277 ↗
• MalfunctionApr 7, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VENOUS SINUS USING A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA GUIDE CATHETER AND A NON-PENUMBRA STENT. DURING THE PROCEDURE, THE 5F SELECT WAS ADVANCED THROUGH THE GUIDE CATHETER. SUBSEQUENTLY, AFTER THE GUIDE CATHETER WAS PLACED IN THE TARGET LOCATION, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE 5F SELECT HAD BROKEN OFF. THE PHYSICIAN THEN USED A SNARE DEVICE AND REMOVED THE DISTAL PIECE OF THE 5F SELECT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING THE SAME GUIDE CATHETER AND A NON-PENUMBRA STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704088 ↗
• InjurySep 28, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON CAROTID USING A NEURON SELECT CATHETER 5F (5F SELECT), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, WHILE REMOVING A 5F SELECT TO COMPLETE THE CASE, THE DISTAL END OF THE 5F SELECT BROKE IN THE DESCENDING AORTA. THE PHYSICIAN THEN USED A SNARE DEVICE TO "LASSO" THE BROKEN TIP. WHILE RETRACTING THE TIP INTO THE BENCHMARK, THE TIP BROKE AGAIN. EVENTUALLY SOME PIECES OF THE TIP FLOWED INTO THE RIGHT CIRCUMFLEX OF THE SUPERFICIAL FEMORAL ARTERY. FROM THERE, THE PHYSICIAN USED A CAT8 TO SUCCESSFULLY REMOVE AT LEAST TWO PIECES OF THE TIP. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO KNOWN ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541080 ↗
• MalfunctionAug 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE FOR A FOUR VESSEL ANGIOGRAM USING A NEURON SELECT CATHETER 5F (5F SELECT), WIRE, NON-PENUMBRA WIRE, AND SHORT FEMORAL SHEATH. DURING THE PROCEDURE, UPON SETTING UP FOR THE DIAGNOSTIC ANGIOGRAM, A 5F SELECT WAS FLUSHED, BUT A WIRE WAS UNABLE TO PASS THROUGH THE LUMEN OF THE 5F SELECT. THEREFORE, THE 5F SELECT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND THE SAME WIRE AND SHORT FEMORAL SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12261969 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)-2019, THE PATIENT UNDERWENT A THROMBECTOMY IN THE CAROTID TERMINUS (CAROTID T) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7). THE PATIENT¿S INITIAL NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS A 11; HOWEVER, THE PRINCIPLE INVESTIGATOR (PI) NOTED THAT THE NIHSS WAS AT 20 LATER IN THE DAY. A STAT COMPUTERIZED TOMOGRAPHY (CT) SHOWS NO BLEED BUT STROKE IN THE RIGHT FRONTAL AND RIGHT PARIETAL LOBE CONSISTENT WITH CT PERFUSION AND CEREBRAL EDEMA. THIS EVENT IS CONSIDERED RESOLVED WITH CLINICAL SEQUELAE AS OF (B)(6) 2019. THESE EVENTS WERE ADJUDICATED TO BE SERIOUS ADVERSE EVENTS WITH A POSSIBLE RELATIONSHIP TO THE JET7 AND PSR3D, AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Edema

  MAUDE report 8804917 ↗
• MalfunctionOct 12, 2016Break; Material Separation; Device Damaged Prior to Use; Break; Material Separation; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE BLACK TIP OF THE NEURON SELECT 5F SELECT CATHETER (5F SELECT) CAME OFF UPON REMOVAL FROM THE PACKAGING. THE TIP OF THE 5F SELECT CAME OFF PRIOR TO USE AND THEREFORE, THE 5F SELECT WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 6021902 ↗

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