Neuron PND6F1056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548010106), received between May 4, 2016 and May 4, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Kinked” (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.

• MalfunctionMay 4, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING NEURON 6F 053 DELIVERY CATHETERS (NEURON 053). DURING THE PROCEDURE, WHILE INTRODUCING A NEURON 053, THE PHYSICIAN NOTICED THAT IT WAS KINKED. THE NEURON 053 WAS THEN REMOVED AND A NEW NEURON 053 WAS OPENED TO CONTINUE THE PROCEDURE. HOWEVER, WHILE IN USE, IT WAS OBSERVED THAT THIS SECOND NEURON 053 WAS KINKED NEAR THE HUB. THEREFORE, THE PHYSICIAN REMOVED THE NEURON 053 AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW NEURON 053. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. PLEASE NOTE THAT EXACT DATE OF EVENT IS UNKNOWN; HOWEVER, THE CUSTOMER INDICATED THAT THE EVENT OCCURRED IN (B)(6) OF 2016.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5630849 ↗

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,