Neuron PNS6F125H1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548012087), received between Jul 1, 2016 and Feb 6, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING NEURON 6F SELECT CATHETERS (6F SELECTS) AND NEURON MAX 6F 088 LONG SHEATHS (NEURON MAXS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A 6F SELECT INTO A NEURON MAX. THE PHYSICIAN, THEREFORE, REPLACED THE ROTATING HEMOSTATIC VALVE (RHV); HOWEVER, WAS STILL UNABLE TO ADVANCE THE 6F SELECT INTO THE NEURON MAX. THE 6F SELECT AND THE NEURON MAX WERE THEREFORE REMOVED, AND A NEW NEURON MAX WAS PLACED INSIDE THE PATIENT. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE A NEW 6F SELECT INTO THE NEW NEURON MAX, AND THEREFORE, THE NEURON MAX AND THE 6F SELECT WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A THIRD 6F SELECT AND A THIRD NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245741 ↗
• MalfunctionFeb 6, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING NEURON 6F SELECT CATHETERS (6F SELECTS) AND NEURON MAX 6F 088 LONG SHEATHS (NEURON MAXS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A 6F SELECT INTO A NEURON MAX. THE PHYSICIAN, THEREFORE, REPLACED THE ROTATING HEMOSTATIC VALVE (RHV); HOWEVER, WAS STILL UNABLE TO ADVANCE THE 6F SELECT INTO THE NEURON MAX. THE 6F SELECT AND THE NEURON MAX WERE THEREFORE REMOVED, AND A NEW NEURON MAX WAS PLACED INSIDE THE PATIENT. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE A NEW 6F SELECT INTO THE NEW NEURON MAX, AND THEREFORE, THE NEURON MAX AND THE 6F SELECT WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A THIRD 6F SELECT AND A THIRD NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245732 ↗
• MalfunctionNov 11, 2016Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE THE PHYSICIAN ADVANCED THE 6F SELECT 6F THROUGH A NON-PENUMBRA SHEATH WITH NO ISSUE; HOWEVER, WHILE RETRACTING THE 6F SELECT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SELECT 6F BECAME STUCK AND UNABLE TO EXIT THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE SHEATH WITH THE SELECT 6F STUCK INSIDE, AND COMPLETED THE PROCEDURE USING A NEW SELECT 6F AND A NEW NON-PENUMBRA SHEATH . THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6095946 ↗
• MalfunctionJul 1, 2016Device Operates Differently Than Expected; Device-Device Incompatibility; Device Operates Differently Than Expected; Device-Device Incompatibility

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, THE 6F SELECT WAS UNABLE TO FIT INTO ANOTHER MANUFACTURER'S SHEATH, THEREFORE IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5766439 ↗

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