Neuron PNS5F130BERRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814548010212), received between Sep 14, 2016 and Dec 19, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING AN ELECTIVE ARTERIOVENOUS MALFORMATION (AVM) CLOSURE PROCEDURE IN THE CEREBRAL ARTERY USING A NEURON SELECT CATHETER 5F (5F SELECT), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL SEGMENT OF THE 5F SELECT HAD FRACTURED IN THE RIGHT VERTEBRAL ARTERY. THE PHYSICIAN THEN USED A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENTS OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND OTHER DEVICES. IT SHOULD BE NOTED THAT THERE WERE NO ALLEGATIONS AGAINST THE FIRST BENCHMARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857883 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A SHORT SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE DISTAL LENGTH OF THE 5F SELECT WHILE ROTATING THE 5F SELECT IN THE COMMON CAROTID ARTERY (CCA). THE FRACTURE WAS OBSERVED UNDER FLUOROSCOPY. A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) WAS USED TO ASPIRATE THE FRACTURED PIECE OF THE 5F SELECT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME BENCHMARK, THE SAME SHORT SHEATH, AND A GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652163 ↗
• InjuryMay 26, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENOUS SINUS USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 5F SELECT OVER A GUIDEWIRE THROUGH THE TORTUOUS INTERNAL CAROTID. NEXT, THE GUIDEWIRE WAS REMOVED TEMPORARILY AND SUBSEQUENTLY, IT WAS NOTICED THAT THE DISTAL TIP OF THE 5F SELECT BROKE OFF. IT WAS ALSO REPORTED THAT THE DISTAL TIP OF THE 5F SELECT WAS FRACTURED AND DISCONNECTED AT THE JUNCTION FROM BLACK TO PURPLE. AFTERWARDS, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN DISTAL TIP OF THE 5F SELECT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891332 ↗
• 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). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE 5F SELECT IN THE COMMON CAROTID ARTERY AND DECIDED TO REMOVE IT. HOWEVER, DURING THE REMOVAL OF THE 5F SELECT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE TIP OF THE 5F SELECT DETACHED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED TIP USING A SNARE DEVICE. IT WAS REPORTED THAT IT TOOK APPROXIMATELY TWO HOURS TO RETRIEVE THE DETACHED TIP. NEXT, WHILE ADVANCING A NEW 5F SELECT, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE IT. HOWEVER, DURING THE REMOVAL OF THE 5F SELECT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE DISTAL END OF THE 5F SELECT BROKE. THE BROKEN DISTAL END OF THE 5F SELECT WAS REMOVED USING A SNARE DEVICE. 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 9602959 ↗
• MalfunctionJul 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE LANTERN APPROXIMATELY THREE FOURTH OF THE WAY THROUGH A NON-PENUMBRA DIAGNOSTIC CATHETER. CONSEQUENTLY, THE LANTERN BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER; THEREFORE, IT WAS RETRACTED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SAME LANTERN THROUGH A NON-PENUMBRA GLIDE CATHETER, ANOTHER NON-PENUMBRA DIAGNOSTIC CATHETER AND A 5F SELECT; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT TWO TREATMENT ZONES WERE PLANNED FOR COILING; HOWEVER, ONE TREATMENT ZONE IN THE TARGET VESSEL WAS NOT ABLE TO BE ACCESSED DUE TO THE COMPATIBILITY ISSUE. THEREFORE, THE PHYSICIAN PLACED A NON-PENUMBRA SHEATH IN THE CELIAC ARTERY AND ADVANCED THE LANTERN OVER A NON-PENUMBRA GUIDEWIRE INTO THE OTHER TREATMENT ZONE AND SUCCESSFULLY PLACED A POD4 AND A POD PACKING COIL (PODJ) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833122 ↗
• MalfunctionMar 26, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF WAS UNABLE TO ADVANCE TWO NEURON SELECT CATHETER 5FS (5F SELECT) OVER A GUIDE WIRE ON THE BACK TABLE; THEREFORE, THEY WERE NOT USED IN THE PROCEDURE. IT WAS REPORTED THAT THE 5F SELECTS WERE KINKED AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER 5F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 8451306 ↗
• MalfunctionMar 26, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF WAS UNABLE TO ADVANCE TWO NEURON SELECT CATHETER 5FS (5F SELECT) OVER A GUIDE WIRE ON THE BACK TABLE; THEREFORE, THEY WERE NOT USED IN THE PROCEDURE. IT WAS REPORTED THAT THE 5F SELECTS WERE KINKED AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER 5F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 8451304 ↗
• InjuryNov 16, 2018Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA SHEATH IN THE LEFT ICA OVER A 5F SELECT AND A NON-PENUMBRA GUIDEWIRE WITHOUT ISSUE, THOUGH THERE WAS SLIGHT RESISTANCE, AND IT WAS REPORTED THERE WAS SLIGHT TORTUOSITY IN THE VESSEL. THE PHYSICIAN THEN REMOVED THE 5F SELECT AND UPON FLUOROSCOPY, IT WAS NOTICED THAT THE TIP OF THE 5F SELECT WAS STILL ON THE SCREEN. AT THAT POINT, THE PHYSICIAN INSPECTED THE 5F SELECT ON THE BACK TABLE AND NOTICED THAT THE ENTIRE BLACK TIP WAS MISSING. AFTER MULTIPLE PASSES WITH VASCULAR RETRIEVERS, THE BROKEN 5F SELECT TIP WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING A CAROTID STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8079518 ↗
• MalfunctionNov 12, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE 5F SELECT THROUGH THE HUB OF A NEURON 6F 070 DELIVERY CATHETER (NEURON 070); THEREFORE, THE 5F SELECT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND THE SAME NEURON 070. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059525 ↗
• MalfunctionAug 3, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FOUND THAT THE NEURON SELECT CATHETER 5F (5F SELECT) WAS FLATTENED IN THE EXTREMITY UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE 5F SELECT WAS FOUND PRIOR TO USE. THEREFORE, THE 5F SELECT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7749488 ↗
• MalfunctionJan 16, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE NEURON SELECT 5F SELECT CATHETER (5F SELECT) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE 5F SELECT WAS FOUND PRIOR TO USE, AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 7197719 ↗
• InjuryOct 11, 2016Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON 5F SELECT CATHETER (5F SELECT). DURING THE PROCEDURE, IN AN ATTEMPT TO ADVANCE THE 5F SELECT THROUGH THE ILIAC ARTERY AND INTO THE AORTA, THE PHYSICIAN ADVANCED THE 5F SELECT THROUGH A NON-PENUMBRA SHEATH; HOWEVER, THE TIP OF THE 5F SELECT BROKE OFF IN THE PATIENT BEFORE THE PHYSICIAN REACHED THE ARCH. THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE BROKEN TIP OF THE 5F SELECT FROM THE AORTA. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6016792 ↗
• MalfunctionOct 5, 2016Break; Material Separation; Out-Of-Box Failure; Break; Material Separation; Out-Of-Box Failure

  WHILE PREPARING A NEURON SELECT CATHETER 5F (5F SELECT) TO BE USED FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THE 5F SELECT TIP SHEARED OFF WHILE BEING ADVANCED THROUGH A NON-PENUMBRA GUIDING CATHETER OUTSIDE OF THE PATIENT'S BODY. THE TIP OF THE 5F SELECT SHEARED OFF PRIOR TO USE AND THEREFORE WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6001141 ↗
• InjurySep 14, 2016Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TREATING A STROKE USING A NEURON 5F SELECT CATHETER (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH A NON-PENUMBRA GUIDE CATHETER, THE TIP OF THE 5F SELECT FRACTURED AND FELL OFF IN THE PATIENT'S AORTA. THEREFORE, THE PHYSICIAN REQUIRED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE BROKEN TIP FROM THE PATIENT PRIOR TO TREATING THE STROKE. THE PHYSICIAN DID NOT MENTION RESISTANCE WHILE USING THE 5F SELECT AND THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. THEREAFTER, THE PHYSICIAN USED ANOTHER MANUFACTURER'S SELECT CATHETER TO SUCCESSFULLY TREAT THE STROKE. THERE WAS A MINIMUM DELAY OF 45 MINUTES IN TREATING THE STROKE DUE TO THE DAMAGED 5F SELECT CATHETER. IT IS UNKNOWN IF THERE WAS AN ADVERSE EFFECT TO THE PATIENT RELATED TO THE DELAY IN THE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5951171 ↗

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