Neuron PND6F11512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548010120), received between Jun 28, 2017 and Jun 28, 2017 — classified as 1 malfunction.

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 (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2017Kinked; 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 DISTAL END OF A NEURON DELIVERY CATHETER 053 (NEURON 053) WAS OVALIZED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 053 WAS FOUND PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 053.

  Patient problems: No Patient Involvement

  MAUDE report 6675165 ↗

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,