Neuron PND6F11512MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548010137), received between Jun 24, 2016 and Mar 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE MICROCATHETER THROUGH THE PROXIMAL HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 053 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832964 ↗
• MalfunctionJun 24, 2016Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Material Integrity Problem; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Material Integrity Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN HAD DIFFICULTY REMOVING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) FROM THEIR SUPPORT MANDRELS AND SUPPORT CARDS. IN ADDITION, THE PHYSICIAN NOTICED THAT THE TIPS OF NEURON 070 AND NEURON 053 WERE DEFORMED. THE DAMAGED NEURON 070 AND NEURON 053 WERE NOTICED PRIOR TO USE AND THEREFORE, WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 5748512 ↗

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