NeuronRecalls & reported problems across all models
Penumbra, Inc. · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 517
- Deaths reported
- 6
- Injuries reported
- 60
- Recalls
- 0
We found 36 models of Neuron by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 517 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2015 and Aug 26, 2026 — classified as 6 deaths, 60 injuries, 451 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (191 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Neuron problems
Device problems
- Device Damaged Prior to Use191
- Break120
- Material Deformation107
- Out-Of-Box Failure104
- Kinked78
- Physical Resistance/Sticking64
- Fracture51
- Failure to Advance50
Patient problems
- No Patient Involvement229
- No Consequences Or Impact To Patient174
- No Clinical Signs, Symptoms or Conditions73
- No Known Impact Or Consequence To Patient12
- Foreign Body In Patient11
- Vasoconstriction9
- Device Embedded In Tissue or Plaque6
- Hemorrhage, Subarachnoid6
Neuron models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Neuron PNML6F088904MCATHETER, PERCUTANEOUS130 reports
- Neuron PNML6F088904CATHETER, PERCUTANEOUS76 reports
- Neuron PNML6F088804MCATHETER, PERCUTANEOUS49 reports
- Neuron PNML6F088804CATHETER, PERCUTANEOUS41 reports
- Neuron PND6F0701058MCATHETER, PERCUTANEOUS38 reports
- Neuron PND6F070956MCATHETER, PERCUTANEOUS25 reports
- Neuron PNS5F130SIMCATHETER, PERCUTANEOUS1 death24 reports
- Neuron PND6F0701058CATHETER, PERCUTANEOUS17 reports
- Neuron PNML6F088904-RCATHETER, PERCUTANEOUS1 death17 reports
- Neuron PNS5F130BERCATHETER, PERCUTANEOUS14 reports
- Neuron PNS6F125BERCATHETER, PERCUTANEOUS13 reports
- Neuron PNS6F125SIMCATHETER, PERCUTANEOUS1 death9 reports
- Neuron PNML6F088904M-RCATHETER, PERCUTANEOUS8 reports
- Neuron PND6F070956CATHETER, PERCUTANEOUS6 reports
- Neuron PNS5F120BERCATHETER, PERCUTANEOUS1 death6 reports
- Neuron PND6F1056MCATHETER, PERCUTANEOUS5 reports
- Neuron PNS5F130H1CATHETER, PERCUTANEOUS4 reports
- Neuron PNS6F125H1CATHETER, PERCUTANEOUS4 reports
- Neuron PNS5F120SIMCATHETER, PERCUTANEOUS3 reports
- Neuron PNML6F0881004MCATHETER, PERCUTANEOUS3 reports
- Neuron PNML6F0881004CATHETER, PERCUTANEOUS1 death3 reports
- Neuron PNML6F088804-RCATHETER, PERCUTANEOUS3 reports
- Neuron PND6F10512CATHETER, PERCUTANEOUS2 reports
- Neuron PND6F11512MCATHETER, PERCUTANEOUS2 reports
- Neuron PND6F1156MCATHETER, PERCUTANEOUS2 reports
- Neuron PNS6F105BERCATHETER, PERCUTANEOUS2 reports
- Neuron PNS5F130SIM-RCATHETER, PERCUTANEOUS2 reports
- Neuron PND6F1056CATHETER, PERCUTANEOUS1 report
- Neuron PND6F11512CATHETER, PERCUTANEOUS1 report
- Neuron PND6F1156CATHETER, PERCUTANEOUS1 report
- Neuron PNS5F120H1CATHETER, PERCUTANEOUS1 report
- Neuron PNS6F125SIMVCATHETER, PERCUTANEOUS1 report
- Neuron PNMD8F088904MCATHETER, PERCUTANEOUS1 report
- Neuron PNML6F0881004-RCATHETER, PERCUTANEOUS1 report
- Neuron PNS6F125H1-RCATHETER, PERCUTANEOUS1 report
- Neuron PNS5F130BER-RCATHETER, PERCUTANEOUS1 death1 report
Recent Neuron adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathAug 26, 2026Fracture
The patient was undergoing a thrombectomy procedure in the M1 segment of the middle cerebral artery (MCA) using a Neuron Select Catheter 5F (5F Select). The physician was advancing the 5F Select in the cervical area and reported that it fractured on the distal length in the common carotid artery (CCA). Several attempts were made to retrieve the fractured segment of the 5F Select using a snare device; however, they were unsuccessful. A balloon device was then used; however, the fractured segment migrated distally. The physician decided to continue the thrombectomy procedure using a stent retriever.After the thrombectomy was completed, the physician found that the 5F Select segment had broken into several smaller fragments. Further attempts were made to retrieve the remaining 5F Select fragments, without success. Some fragments remained in the internal carotid artery (ICA). The physician decided to terminate the procedure at this point.It was reported that the patient expired the following day on (b)(6) 2026. The cause of death is unknown.
Patient problems: Foreign Body In Patient
MAUDE report 50453404 ↗MalfunctionAug 6, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50162832 ↗InjuryMar 20, 2026Fracture
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHEATH (6F), AND A GUIDEWIRE (0.038). THE PHYSICIAN GAINED RIGHT RADIAL ACCESS AND ADVANCED THE BENCHMARK AND THE 5F SELECT THROUGH THE SHEATH OVER THE GUIDEWIRE TO THE AORTIC ARCH. THE BENCHMARK WAS THEN PLACED IN THE SUBCLAVIAN ARTERY. WHILE SELECTING THE ICA USING THE 5F SELECT, THE PHYSICIAN OBSERVED THAT THE 5F SELECT APPEARED TO BE DAMAGED UNDER FLUOROSCOPY. THE PHYSICIAN DECIDED TO REMOVE 5F SELECT. WHILE RETRACTING THE 5F SELECT, THE 5F SELECT FRACTURED AT THE DISTAL END IN THE AORTIC ARCH. THE 5F SELECT WAS REMOVED AND THE FRACTURED PORTION REMAINED IN THE AORTIC ARCH WHILE THE PHYSICIAN CONTINUED THE COIL EMBOLIZATION PROCEDURE USING ANOTHER 5F SELECT. AFTER COMPLETION OF THE COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN GAINED RIGHT FEMORAL ACCESS AND A 9F SHEATH WAS PLACED. THE PHYSICIAN ADVANCED A SNARE DEVICE TO RETRIEVE THE FRACTURED 5F SELECT SEGMENT. WHILE RETRACTING INTO THE SHEATH, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT FRACTURED AT THE DISTAL
Patient problems: Foreign Body In Patient
MAUDE report 24654851 ↗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 ↗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 ↗MalfunctionJun 2, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT UNDERWENT A MEDICAL PROCEDURE IN THE VERTEBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE THROUGH THE DISTAL LENGTH OF THE NEURON MAX. AFTER COMPLETING THE PROCEDURE, THE PHYSICIAN RETRACTED THE NEURON MAX OUT OF THE PATIENT AND FOUND THAT IT WAS DAMAGED AT THE DISTAL END. AT THIS POINT, THE PROCEDURE WAS ALREADY COMPLETED AND NO ADDITIONAL DEVICES WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22128419 ↗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 ↗DeathApr 18, 2025Material Fragmentation; Material Fragmentation
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WITH SOME DIFFICULTY, THE NEURON MAX WAS ADVANCED THROUGH A STENT AT THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. UPON REMOVAL OF THE NEURON MAX 6F SELECT INNER CATHETER, THE NEURON MAX DISTAL TIP WAS FOUND TO BE FRACTURED. CONTRAST INJECTION DEMONSTRATED MINIMAL FLOW INTO THE LEFT MIDDLE CEREBRAL ARTERY AS WELL AS THE LEFT ANTERIOR CEREBRAL ARTERY DUE TO THE FRACTURED NEURON MAX SEGMENT. ATTEMPTS TO RETRIEVE THE NEURON MAX FRACTURED SEGMENT WERE UNSUCCESSFUL FOLLOWED BY GROSS SUBARACHNOID HEMORRHAGE. SUBSEQUENT COIL OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY WAS PERFORMED TO CONTROL BLEEDING. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. POST-PROCEDURE, THE PATIENT REMAINED INTUBATED, NOT SEDATED, REQUIRING FOUR VASOPRESSORS. THE PATIENT HAD NO COUGH, GAG, OR CORNEAL REFLEX. PUPILS WERE 7MM AND NONREACTIVE BILATERALLY. DISCUSSION WITH THE SPOUSE/FAMILY GIVEN HEMODYNAMIC INSTABILITY AND UNLIKELY MEANINGFUL OUTCOME. THE FAMILY DECIDED TO TRANSITION TO COMFORT CARE, AND THE PATIENT EXPIRED ON (B)(6) 2025.
Patient problems: Brain Injury; Foreign Body Embolism; Intracranial Hemorrhage
MAUDE report 21869144 ↗InjuryJan 2, 2025Fracture; Migration; Fracture; Migration
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN THE MIDDLE CEREBRAL ARTERY (MCA) SUPERIOR BRANCH USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA SHEATH (8F SHORT SHEATH), A NON-PENUMBRA GUIDE CATHETER, AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE NEURON MAX INTO THE INTERNAL CAROTID ARTERY (ICA) USING THE SHEATH. WHILE ATTEMPTING TO INTRODUCE THE MICROCATHETER TO THE SUPERIOR BRANCH OF THE MCA, THE PHYSICIAN NOTICED CLOT FORMATION. UPON FURTHER INSPECTION, THE PHYSICIAN FOUND THAT THE MARKERBAND OF THE NEURON MAX HAD DISCONNECTED FROM THE TIP AND WAS FOUND IN THE MCA, AND A PIECE OF THE DISTAL END OF THE NEURON MAX HAD DETACHED AND MIGRATED INTO THE MCA. THE PHYSICIAN BELIEVED THAT THE CLOT FORMATION OCCURRED DUE TO THE MARKERBAND DETACHMENT. THE PHYSICIAN DECIDED TO ADMINISTER HEPARIN TO TREAT THE CLOT FORMATION; HOWEVER, IT DID NOT RESOLVE. THE PATIENT THEN EXPERIENCED AN ACUTE STROKE ON THE OPERATING TABLE. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE STROKE WAS CAUSED BY THE DAMAGE TO THE NEURON MAX. THE NEURON MAX, GUIDE CATHETER, AND MICROCATHETER WERE THEN REMOVED
Patient problems: Stroke/CVA
MAUDE report 21061309 ↗MalfunctionNov 13, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE NEURON MAX OVER THE AORTIC ARCH, THE PHYSICIAN EXPERIENCED RESISTANCE AND OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT WAS FRACTURED ON THE DISTAL LENGTH. THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE FRACTURED PART OF THE 5F SELECT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675504 ↗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 ↗MalfunctionOct 25, 2024Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A GUIDEWIRE (0.035 INCH) VIA A TRANSRADIAL APPROACH. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THERE WAS NO MOVEMENT OF THE 5F SELECT UNDER FLUOROSCOPY. THE PHYSICIAN THEN NOTICED THAT THE 5F SELECT WAS FRACTURED AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENT OF THE 5F SELECT WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. THE PHYSICIAN THEN ADVANCED A SECOND 5F SELECT INTO THE TARGET LOCATION. AFTER ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT WAS FRACTURED INTO THREE PIECES AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENTS OF THE 5F SELECT WERE REMOVED FROM THE PATIENT USING THE SAME SNARE DEVICE. AT THIS POINT, THE PROCEDURE WAS CONVERTED INTO FEMORAL ACCESS USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20534421 ↗MalfunctionOct 25, 2024Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A GUIDEWIRE (0.035 INCH) VIA A TRANSRADIAL APPROACH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THERE WAS NO MOVEMENT OF THE 5F SELECT UNDER FLUOROSCOPY. THE PHYSICIAN THEN NOTICED THAT THE 5F SELECT WAS FRACTURED AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENT OF THE 5F SELECT WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. THE PHYSICIAN THEN ADVANCED A SECOND 5F SELECT INTO THE TARGET LOCATION. AFTER ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT WAS FRACTURED INTO THREE PIECES AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENTS OF THE 5F SELECT WERE REMOVED FROM THE PATIENT USING THE SAME SNARE DEVICE. AT THIS POINT, THE PROCEDURE WAS CONVERTED INTO FEMORAL ACCESS USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20534217 ↗MalfunctionSep 6, 2024Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO PERFORM ANGIOGRAPHY USING A NEURON SELECT CATHETERS 5F (5F SELECT) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 5F SELECT THROUGH THE RIGHT COMMON CAROTID ARTERY (CCA) TO PERFORM AN ANGIOGRAPHY VIA RADIAL ACCESS, THE PHYSICIAN FRACTURED THE 5F SELECT AT THE DISTAL LENGTH IN THE RIGHT SUBCLAVIAN ARTERY. THEREFORE, THE PHYSICIAN REMOVED THE 5F SELECT AND USED A SNARE DEVICE TO REMOVE THE FRACTURED SEGMENT OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157120 ↗MalfunctionJul 26, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AN ANGIOGRAPHIC CATHETER (5F), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT HAD A TYPE III ARCH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON MAX. THE PHYSICIAN THEN DECIDED TO REMOVE THE NEURON MAX FROM THE PATIENT. AFTER REMOVING THE NEURON MAX, THE PHYSICIAN FOUND THAT IT WAS FRACTURED AT THE DISTAL END. THEREFORE, THE NEURON MAX WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, THE SAME ANGIOGRAPHIC CATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19844257 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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