Neuron PNS6F105BERRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548012131), received between Apr 27, 2016 and Dec 28, 2017 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A DIAGNOSTIC PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 6F SELECT THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE 6F SELECT APPROXIMATELY TWENTY CENTIMETERS INTO THE NEURON MAX. THEREFORE, THE 6F SELECT WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW NEURON 5F SELECT CATHETER (5F SELECT) AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7153320 ↗
• InjuryApr 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX SEPARATOR, A PX SLIM DELIVERY MICROCATHETER, A NEURON 6F SELECT CATHETER AND A NEURON MAX 6F 088 LONG SHEATH. ON POST-OPERATIVE DAY 1 AND DAY 3, A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) WAS PERFORMED AND REVEALED EVIDENCE OF A SUBARACHNOID HEMORRHAGE (SAH) IN THE DORSAL INSULA AND HEMORRHAGIC TRANSFORMATION. THE SAH WAS NOTED TO BE DUE TO VESSEL PERFORATION. THE PATIENT SHOWED OVERALL CLINICAL IMPROVEMENT IN NEUROLOGICAL STATUS AND WAS MAINTAINED ON DILTIAZEM AND ATENOLOL FOR ATRIAL FIBRILLATION THROUGHOUT THE HOSPITAL STAY. ON (B)(6) 2012, THE PATIENT WAS SUBSEQUENTLY DISCHARGED TO AN ACUTE REHABILITATION NURSING FACILITY. THE SAH WAS REVIEWED AND ADJUDICATED BY THE COMMITTEE TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE BUT UNRELATED TO THE INDEX STOKE.

  Patient problems: Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5612105 ↗

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