Neuron PND6F0701058Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00814548010045), received between Mar 30, 2016 and Sep 25, 2020 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE BY FLOW DIVERSION IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A NEURON 070 THROUGH THE NEURON MAX AND SUBSEQUENTLY, THE NEURON 070 WAS UNABLE TO ADVANCE THROUGH THE NEURON MAX. THEREFORE, THE NEURON MAX WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SAME NEURON 070 INTO A NEW NEURON MAX; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME SECOND 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 10586368 ↗
• MalfunctionMay 21, 2019Collapse; Device Damaged Prior to Use; Collapse; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL TECHNICIAN FOUND THAT A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS FLATTENED WHILE ATTEMPTING TO ADVANCE A GUIDE WIRE THROUGH IT. 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 8629392 ↗
• MalfunctionMar 8, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS FLATTENED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE DEVICE 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 8404338 ↗
• MalfunctionJan 4, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT CAROTID ARTERY USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A GUIDEWIRE THROUGH THE NEURON 070 AND FOUND THE DISTAL THIRD OF THE NEURON 070 TO BE OVALIZED WHILE ADVANCING THROUGH THE AORTA AND AORTIC ARCH WITHIN A NON-PENUMBRA SHEATH; THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER WITH THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219190 ↗
• MalfunctionNov 21, 2018Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF OPENED A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND FOUND THE DISTAL END TO BE KINKED. THE HOSPITAL STAFF THEN OPENED A SECOND NEURON 070 AND NOTICED THE SAME TYPE OF DAMAGE TO THE DISTAL END. THE DAMAGE TO BOTH NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8098024 ↗
• MalfunctionNov 21, 2018Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF OPENED A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND FOUND THE DISTAL END TO BE KINKED. THE HOSPITAL STAFF THEN OPENED A SECOND NEURON 070 AND NOTICED THE SAME TYPE OF DAMAGE TO THE DISTAL END. THE DAMAGE TO BOTH NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8098022 ↗
• MalfunctionSep 7, 2018Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A NEURON DELIVERY CATHETER 070 (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON 070 IN THE PATIENT¿S BODY AND HOOKED UP THE FLUSH; HOWEVER, A SMALL HOLE WAS NOTICED AND THE NEURON 070 WAS LEAKING FLUID. THEREFORE, IT WAS REMOVED. 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 7857545 ↗
• MalfunctionAug 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS LEAKING WHEN THEY FLUSHED IT 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 7819990 ↗
• MalfunctionDec 27, 2017Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE USING NEURON 6F 070 DELIVERY CATHETERS (NEURON 070S). DURING THE PROCEDURE, THE NEURON 070 WAS LEAKING NEAR THE HUB IN THE STRAIN RELIEF AREA; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149420 ↗
• MalfunctionDec 15, 2017Break; 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 SCRUB TECHNOLOGIST REMOVED THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) FROM ITS PACKAGING. UPON FLUSHING THE NEURON 070, THE TECHNOLOGIST NOTICED THAT THE NEURON 070 WAS BROKEN. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE IN THE PATIENT AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7123978 ↗
• MalfunctionJul 20, 2017Collapse; Device Damaged Prior to Use; Out-Of-Box Failure; Collapse; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE DISTAL END OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS COLLAPSED UPON REMOVAL FROM THE PACKAGING. FURTHERMORE, A GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE LUMEN OF THE NEURON 070. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 6730745 ↗
• MalfunctionMar 15, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON DELIVERY CATHETER 070 (NEURON 070). DURING THE PROCEDURE, AFTER SUCCESSFULLY MAKING PASSES, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A STENT THROUGH THE NEURON 070 AND THE NEURON 070 BECAME STRETCHED. THEREFORE, THE NEURON 070 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6407004 ↗
• MalfunctionJan 24, 2017Collapse; Device Damaged Prior to Use; Out-Of-Box Failure; Collapse; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THE TIP OF THE NEURON DELIVERY CATHETER 070 (NEURON 070) WAS CRUSHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 070 WAS NOTICED PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 6274670 ↗
• MalfunctionDec 27, 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 MULTIPLE KINKS ON THE DISTAL END OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) UPON REMOVAL FROM THE PACKAGING. THE KINKED 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 6207588 ↗
• MalfunctionDec 8, 2016Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem; Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THAT THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS "SCRUNCHED"/"KNEADED" UPON REMOVAL FROM THE PACKAGING BOX. THE DAMAGED 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 6156820 ↗
• MalfunctionJul 22, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, WHILE CONNECTING THE PERFUSION DEVICES, THE PHYSICIAN NOTICED THAT SALINE SOLUTION WAS LEAKING FROM THE HUB OF THE NEURON 070 TO THE PROXIMAL SHAFT CONNECTION. THEREFORE, THE NEURON 070 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5816843 ↗
• MalfunctionMar 30, 2016Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem; Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 5535483 ↗

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,