Neuron PND6F070956MRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00814548010076), received between Sep 3, 2015 and Mar 27, 2024 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K082290); 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2024Fracture; Stretched; Material Deformation; Physical Resistance/Sticking; Fracture; Stretched; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE CAROTID ARTERY USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE NEURON 070 INTO THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON 070 BECAME STUCK IN THE PELVIS. THEREFORE, THE PHYSICIAN REMOVED THE SHEATH, NEURON 070 AND GUIDEWIRE TOGETHER. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL LENGTH OF THE NEURON 070 HAD STRETCHED AND OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND A NEW NON-PENUMBRA SHEATH. 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 18986181 ↗
• MalfunctionNov 16, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SYSTEM JET 7 REPERFUSION CATHETERS (JET7)S AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE JET7 WAS LEAKING JUST BEYOND THE HUB ON THE BACK TABLE. THEREFORE, THE JET7 WAS NOT USED IN THE PROCEDURE. ANOTHER JET7 WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS ALSO REPORTED THAT WHILE THE NEURON MAX WAS STILL INSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS KINKED; THE NEURON MAX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10847224 ↗
• MalfunctionSep 7, 2020Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A NON-PENUMBRA CATHETER AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NON-PENUMBRA CATHETER THROUGH THE NEURON 070, THEN INSERTED THE STENT RETRIEVER THROUGH THE NON-PENUMBRA CATHETER. AFTER COMPLETING A PASS USING THE SOLUMBRA TECHNIQUE, THE PHYSICIAN ATTEMPTED TO PULL THE STENT RETRIEVER INTO THE NON-PENUMBRA CATHETER AND RETRACT BOTH DEVICES; HOWEVER, THE STENT RETRIEVER AND CATHETER BECAME STUCK WITHIN THE NEURON 070. THEREFORE, THE NEURON 070, NON-PENUMBRA CATHETER AND STENT RETRIEVER WERE REMOVED TOGETHER. UPON REMOVAL, IT WAS NOTICED THAT THE DEVICES WERE TWISTED TOGETHER. THE PROCEDURE WAS COMPLETED USING NEW DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10499453 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON ADDITIONAL INFORMATION RECEIVED ON 25-FEB-2020, THERE WAS NO ALLEGED DEFICIENCY RELATED TO ANY PENUMBRA DEVICE. THE ADVERSE EVENT WAS DETERMINED TO BE UNRELATED TO ANY PENUMBRA DEVICE AND, THEREFORE, THIS IS NOT A VALID COMPLAINT.

  Patient problems: Edema

  MAUDE report 8809381 ↗
• MalfunctionJun 21, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING A PENUMBRA SMART COILS (SMART COILS) AND POD5. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, IT GOT STUCK; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING THE LAST 3 MM OF THE POD5 INTO THE ANEURYSM AND THE MICROCATHETER KICKED BACK. THEREFORE, THE POD5 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE ANEURYSM. THE SMART COIL WAS DETACHED USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE); HOWEVER, WHILE RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, IT WAS NOTED UNDER FLUOROSCOPY THAT THE SMART COIL WAS NOT DETACHED FROM THE PUSHER ASSEMBLY. THE PHYSICIAN INDICATED THAT PART OF THE SMART COIL REMAINED WITHIN THE MICROCATHETER AND PART OF THE SMART COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE MICROCATHETER WAS REMOVED FROM THE PATIENT WITH THE SMART COIL SEGMENT IN IT. THE PROCEDURE WAS ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724921 ↗
• MalfunctionMar 8, 2019Unraveled Material; Device Damaged Prior to Use; Unraveled Material; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A HOSPITAL STAFF MEMBER FOUND THAT THE DISTAL TIP OF THE NEURON 070 HAD UNRAVELED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8404727 ↗
• MalfunctionJan 25, 2019Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE RADIO-OPAQUE MARKER OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS PEELED OFF UPON REMOVAL FROM PACKAGING. THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8279064 ↗
• MalfunctionJan 10, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) BECAME KINKED ON BOTH ENDS UPON REMOVAL FROM PACKAGING. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8235958 ↗
• MalfunctionAug 8, 2018Defective Device; Defective Device

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS DAMAGED WHEN THE PHYSICIAN WANTED TO FLUSH THE DEVICE ON THE BACK TABLE. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7764133 ↗
• MalfunctionAug 1, 2018Defective Device; Defective Device

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS RUINED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7741386 ↗
• MalfunctionDec 6, 2017Stretched; Device Damaged Prior to Use; Out-Of-Box Failure; Stretched; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS STRETCHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7086799 ↗
• MalfunctionOct 5, 2017Kinked; Failure to Advance; Difficult to Advance; Kinked; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE NEURON 070 INTO THE LESION, THE PHYSICIAN EXPERIENCED DIFFICULTY AND DECIDED TO REMOVE THE NEURON 070. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE NEURON 070 WAS KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6915739 ↗
• MalfunctionSep 7, 2017Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS FRACTURED AT THE DISTAL TIP UPON REMOVAL FROM THE PACKAGING. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 6849513 ↗
• MalfunctionApr 4, 2017Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS KINKED. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 6457110 ↗
• MalfunctionAug 22, 2016Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE TECHNOLOGIST NOTICED THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) CAME OFF UPON REMOVAL FROM THE PACKAGING. THE BROKEN NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 5895194 ↗
• MalfunctionMay 13, 2016Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). AFTER ADMINISTRATING GLUE TO THE PATIENT AND UPON REMOVAL OF THE NEURON 070 FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE NEURON 070 WAS BROKEN AT THE HUB. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5654343 ↗
• MalfunctionApr 12, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS KINKED. THE KINKED NEURON 070 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 5571705 ↗
• MalfunctionApr 6, 2016Material Separation; Unraveled Material; Out-Of-Box Failure; Material Separation; Unraveled Material; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) BECAME DETACHED FROM THE SHAFT OF THE CATHETER AFTER THE PROTECTIVE MANDREL WAS REMOVED FROM THE CARDBOARD BACKING AND PULLED AWAY FROM THE TIP OF THE NEURON 070. AS A RESULT OF THE NEURON 070 TIP DETACHING, THE BRAIDING WIRE WITHIN THE NEURON 070 BEGAN TO UNRAVEL. THE SCRUB NURSE STATED THAT THE END OF THE NEURON 070 WAS SECURELY STUCK TO THE MANDREL. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 5552669 ↗
• MalfunctionMar 4, 2016Kinked

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS KINKED. THE KINKED NEURON 070 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5480073 ↗
• MalfunctionJan 29, 2016Device Damaged Prior to Use; Out-Of-Box Failure; Material Protrusion/Extrusion; Device Damaged Prior to Use; Out-Of-Box Failure; Material Protrusion/Extrusion

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A STAINLESS WIRE WAS COMING OUT OF THE TIP OF A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 5399343 ↗
• MalfunctionJan 6, 2016Out-Of-Box Failure; Difficult to Open or Remove Packaging Material; Failure To Unwrap; Out-Of-Box Failure; Difficult to Open or Remove Packaging Material; Failure To Unwrap

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PACKAGING MANDREL OF A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS STUCK AND UNABLE TO BE REMOVED UPON REMOVAL OF THE NEURON 070 FROM ITS PACKAGING. THE DEFECTIVE NEURON 070 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 5349429 ↗
• MalfunctionNov 18, 2015Kinked; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, IT WAS NOTICED THAT THE NEURON 070 DELIVERY CATHETER (NEURON 070) WAS KINKED AT THE MID SHAFT AND THE BENCHMARK 071 DELIVERY CATHETER (BENCHMARK DC) WAS OVALIZED AT THE TIP. THE DAMAGED NEURON 070 AND BENCHMARK DC WERE FOUND PRIOR TO USE AND WERE NOT USED IN THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW NEURON 070 AND BENCHMARK DC.

  Patient problems: No Patient Involvement

  MAUDE report 5234868 ↗
• MalfunctionNov 6, 2015Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, WHILE REMOVING THE NEURON 070 FROM ANOTHER MANUFACTURER'S ROTATING HEMOSTASIS VALVE (RHV) CONNECTOR, THE NEURON 070 BECAME OVALIZED. THE PROCEDURE CONTINUED USING A NEW NEURON 070. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5208217 ↗
• MalfunctionSep 11, 2015Out-Of-Box Failure; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON DELIVERY CATHETER 070 (NEURON 070). UPON REMOVAL FROM THE PACKAGING, THE TIP OF THE NEURON 070 WAS FOUND OVALIZED AND WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW NEURON 070.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5072203 ↗
• MalfunctionSep 3, 2015Kinked; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON DELIVERY CATHETER 070 (NEURON 070). UPON REMOVAL FROM THE PACKAGING, THE NEURON 070 WAS FOUND KINKED AND WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW NEURON 070.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 5054745 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082290. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2010 · Sep 22, 2009 · Terminated
  Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda,