Neuron PND6F1056MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548010113), received between May 19, 2016 and Feb 22, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2018Kinked; 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 FOUND THAT THE NEURON 6F 053 DELIVERY CATHETER (NEURON 053) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 053 WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 053.

  Patient problems: No Patient Involvement

  MAUDE report 7289236 ↗
• MalfunctionJan 5, 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 TIP OF A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED NEURON 053 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 053.

  Patient problems: No Patient Involvement

  MAUDE report 7166889 ↗
• MalfunctionOct 19, 2017Break; Hole In Material; Break; Hole In Material

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 053 DELIVERY CATHETER (NEURON 053). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON 053 THROUGH A NON-PENUMBRA SHEATH AND INTO THE TARGET LOCATION. THE PHYSICIAN THEN NOTICED A HOLE OR BREAK IN THE NEURON 053 WHEN CONTRAST WAS INJECTED THROUGH IT. THE PHYSICIAN WAS UNSURE HOW THE BREAK OCCURRED BUT BELIEVED THAT IT HAPPENED AT A KINK IN THE PROXIMAL INTERNAL CAROTID ARTERY (ICA). AFTER THAT, THE PHYSICIAN NOTED A ¿BREAK DOWN¿ AT THE TIP OF A NON-PENUMBRA GUIDEWIRE, WHICH WAS RETRIEVED USING A SNARE DEVICE. IT WAS REPORTED THAT THE BREAKAGE OF THE GUIDEWIRE HAD NOTHING TO DO WITH ANY PENUMBRA DEVICES. THE PROCEDURE WAS THEN COMPLETED USING THE SAME NEURON 053 DESPITE THE FACT THAT IT WAS LEAKING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963211 ↗
• MalfunctionApr 20, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE DISTAL END OF A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 053 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 053.

  Patient problems: No Patient Involvement

  MAUDE report 6509133 ↗
• MalfunctionMay 19, 2016Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) WAS BENT UPON REMOVAL FROM THE PACKAGING. THE BENT TIP OF THE NEURON 053 WAS FOUND PRIOR TO USE AND THEREFORE, THE NEURON 053 WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 053.

  Patient problems: No Patient Involvement

  MAUDE report 5667467 ↗

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,