Neuron PNS6F125SIMVRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548012063), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2018Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON SELECT CATHETER 6F (6F SELECT) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) PRIOR TO INSERTING INTO THE PATIENT'S BODY. THEREFORE, THE 6F SELECT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 6F SELECT AND THE SAME NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8035445 ↗

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