Neuron PNS6F125BERRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00814548012094), received between Apr 29, 2016 and Sep 1, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K070970); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE 6F SELECT TO DELIVER THE GUIDEWIRE TO THE TARGET LOCATION TO PREPARE FOR CANNULATION. WHILE REMOVING THE 6F SELECT FROM THE PATIENT, THE PHYSICIAN VISUALIZED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE 6F SELECT HAD FRACTURED INTO TWO PIECES. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED PIECE OF THE 6F SELECT USING A SNARE AND A CATHETER AND FRACTURED IT AGAIN. APPROXIMATELY THREE CENTIMETERS OF THE DISTAL END PIECE OF THE 6F SELECT WAS ABLE TO BE REMOVED FROM THE PATIENT AND THE LAST PIECE OF THE 6F SELECT REMAINED IN A SMALL BRANCH OF THE RIGHT PULMONARY ARTERY. THE PHYSICIAN DECIDED TO LEAVE THE REMAINING PIECE OF THE 6F SELECT IN THE PATIENT AS IT WAS DEEMED THAT IT WOULD NOT HARM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), THE SAME SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674380 ↗
• MalfunctionJan 28, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE PULMONARY ARTERY USING A NEURON SELECT CATHETER 6F (6F SELECT). DURING THE PROCEDURE, THE 6F SELECT TIP BROKE OFF IN THE PULMONARY ARTERY. THE BROKEN PART OF THE 6F SELECT WAS RETRIEVED SUCCESSFULLY. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389421 ↗
• InjuryOct 14, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VERTEBRAL ARTERY USING A NEURON SELECT CATHETER 6F (6F SELECT) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO RETRACT THE 6F SELECT TO CHANGE TO A DIFFERENT CATHETER. WHILE RETRACTING, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TIP OF THE 6F SELECT BROKE. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN TIP OF THE 6F SELECT. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE STROKE RESOLVED ITSELF WITH THE TISSUE PLASMINOGEN ACTIVATOR (TPA) THAT HAD BEEN ADMINISTERED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636558 ↗
• MalfunctionNov 2, 2018Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A NEURON 6F SELECT CATHETER (6F SELECT) WOULD NOT ADVANCE ALL THE WAY THROUGH THE DISTAL TIP OF A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) ON THE BACK TABLE; THEREFORE, BOTH NEURON MAX AND 6F SELECT WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND 6F SELECT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035638 ↗
• MalfunctionAug 15, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A 6F SELECT THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE 6F SELECT WOULD NOT TRACK INSIDE THE NEURON MAX; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 6F SELECT AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785982 ↗
• MalfunctionJan 9, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT A NEURON 6F SELECT CATHETER (6F SELECT) INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) ON THE BACK TABLE; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE 6F SELECT DID NOT FIT INTO THE NEURON MAX. IT WAS ALSO REPORTED THAT THE PHYSICIAN ALSO HAD DIFFICULTY ADVANCING THE NEURON MAX THROUGH AN 8F SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW 6F SELECT, THE SAME NEURON MAX AND SAME 8F SHEATH.

  Patient problems: No Patient Involvement

  MAUDE report 7175896 ↗
• MalfunctionJan 3, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON SELECT CATHETER 6F (6F SELECT). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 6F SELECT THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE 6F SELECT WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162046 ↗
• MalfunctionDec 28, 2017Failure to Advance; Failure to Advance

  WHILE PREPARING A NEURON SELECT CATHETER 6F (6F SELECT) FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN FLUSHED THE 6F SELECT AND ATTEMPTED TO LOAD A GLIDEWIRE THROUGH IT; HOWEVER, THE GLIDEWIRE WOULD NOT ADVANCE. THEREFORE, THE 6F SELECT WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING ANOTHER 6F SELECT AND THE SAME WIRE.

  Patient problems: No Patient Involvement

  MAUDE report 7153014 ↗
• MalfunctionOct 25, 2017Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A NEURON 6F SELECT CATHETER (6F SELECT) INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) ON THE BACK TABLE. IT WAS REPORTED THAT THE PHYSICIAN MADE SEVERAL ATTEMPTS TO LOAD THE 6F SELECT INTO THE NEURON MAX AND EVEN THOUGH IT COULD BE FORCED THROUGH, THE 6F SELECT DID NOT MOVE FREELY. THEREFORE, THE 6F SELECT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEURON SELECT CATHETER 5F (5F SELECT) AND THE SAME NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6977840 ↗
• MalfunctionJun 30, 2017Retraction Problem; Physical Resistance; Mechanical Jam; Retraction Problem; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN EMERGENT LARGE VESSEL OCCLUSION USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE COMMON CAROTID ARTERY (CCA) AND THEN ADVANCED THE 6F SELECT THROUGH THE NEURON MAX TO GAIN ACCESS TO THE TARGET VESSEL IN THE INTERNAL CAROTID ARTERY (ICA). ONCE THE NEURON MAX WAS IN PLACE, THE PHYSICIAN ATTEMPTED TO RETRACT THE 6F SELECT FROM THE NEURON MAX; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE 6F SELECT BECAME STUCK IN THE NEURON MAX AND WOULD NOT RETRACT. THEREFORE, THE PHYSICIAN REMOVED BOTH THE NEURON MAX AND THE 6F SELECT AND COMPLETED THE PROCEDURE USING A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6681154 ↗
• MalfunctionOct 19, 2016Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE 6F SELECT THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE 6F SELECT WOULD NOT PHYSICALLY FIT THROUGH THE NEURON MAX. THEREFORE, THE 6F SELECT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 6F SELECT AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6041503 ↗
• MalfunctionSep 28, 2016Device Damaged Prior to Use; Failure to Advance; Material Deformation; Device Damaged Prior to Use; Failure to Advance; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE THE PHYSICIAN WAS UNABLE TO ADVANCE A NEURON SELECT CATHETER 6F (6F SELECT) THROUGH THE HUB OF A NEURON MAX 088 (NEURON MAX) ON THE BACK TABLE. THE PHYSICIAN NOTICED A SLIGHT BULGE AT THE DISTAL END NEAR THE TRANSITION OF THE 6F SELECT. THE DAMAGED 6F SELECT WAS FOUND PRIOR TO USE; THEREFORE, IT WAS NEVER USED. THE PROCEDURE WAS COMPLETED USING A NEW 6F AND THE SAME NEURON MAX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 5983225 ↗
• InjuryApr 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER, A VELOCITY DELIVERY MICROCATHETER, A NEURON MAX 8F 088 DELIVERY CATHETER AND A NEURON 6F SELECT CATHETER AND COMPLETE RECANALIZATION OF THE TARGET VESSEL WAS ACHIEVED. HOWEVER, AFTER THE PROCEDURE THE PATIENT WENT INTO ATRIAL FIBRILLATION (A-FIB) AND WAS IMMEDIATELY GIVEN 25 MG OF IV CARDIZEM BEFORE BECOMING HYPOTENSIVE. ON POSTOPERATIVE DAY 1 ((B)(6) 2014), A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AS A ROUTINE FOLLOW-UP. UPON RETURN, THERE WAS ABNORMAL EXTENSION IN THE PATIENT¿S RIGHT UPPER EXTREMITY (RUE) AND DIMINISHED CORNEAL. THE MRI SCANS DEMONSTRATED LARGE AREAS OF ACUTE/SUBACUTE INFARCTION IN THE LEFT CEREBRAL HEMISPHERE, PREDOMINANTLY IN THE MIDDLE CEREBRAL ARTERY (MCA) DISTRIBUTION, BUT ALSO WITHIN THE ANTERIOR CEREBRAL ARTERY (ACA) AND POSTERIOR CEREBRAL ARTERY (PCA) DISTRIBUTIONS. A MAGNETIC RESONANCE ANGIOGRAM (MRA) DEMONSTRATED OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY (ICA) AND MCA. LATER, ON THE SAME DAY ((B)(6)2014), A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) WAS PERFORMED AND SHOWED SUBACUTE LEFT MCA INFA

  Patient problems: Atrial Fibrillation; Infarction, Cerebral; Reocclusion

  MAUDE report 5619645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070970. One submission often covers many models, so check the product and lot details in each record.

• Z-2313-2009 · Jul 1, 2009 · Terminated
  Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional device