Neuron PND6F070956Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814548010069), received between Apr 8, 2016 and Dec 19, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), THE HOSPITAL STAFF FOUND THAT THE NEURON 070 WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8179082 ↗
• MalfunctionMay 31, 2018Collapse; Failure to Advance; Collapse; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE NEURON 070 INTO ITS INTRODUCER SHEATH. THE PHYSICIAN USED A GUIDEWIRE TO TRY TO ADVANCE THE NEURON 070, HOWEVER WAS STILL UNABLE TO ADVANCE INTO THE INTRODUCER SHEATH. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE NEURON 070 INTO THE NON-PENUMBRA CATHETER WITHOUT USING THE INTRODUCER SHEATH AND, CONSEQUENTLY, THE NEURON 070 CRUMPLED. THE PROCEDURE WAS THEN COMPLETED USING A NEW NEURON 070 WITH ITS INTRODUCER SHEATH AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557754 ↗
• MalfunctionFeb 9, 2018Physical Resistance; Folded; Physical Resistance; Folded

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON DELIVERY CATHETER 070 (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON 070 TO THE TARGET LOCATION AFTER BEING ADVANCED THROUGH A SHEATH, AND THEREFORE THE NEURON 070 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE NEURON 070 HAD BECOME KINKED AND HAD AN "ACCORDION AFFECT". THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW NEURON 070 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 7261660 ↗
• MalfunctionSep 19, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem; Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE TECHNOLOGIST NOTICED THAT THE DISTAL TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS CRIMPED UPON REMOVING IT FROM THE PACKAGING. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 6877361 ↗
• MalfunctionJun 28, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING NEURON 6F 070 DELIVERY CATHETERS (NEURON 070¿S) AND RUBY COILS. IT WAS NOTED THAT THE PATIENT HAD A VERY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO GAIN ACCESS USING A NON-PENUMBRA 6F SHEATH AND A NEURON 070, WITH A NON-PENUMBRA SELECT CATHETER LOADED IN THE NEURON 070. WHILE ATTEMPTING TO ADVANCE THE NEURON 070 THROUGH THE SHEATH, THE PHYSICIAN INADVERTENTLY KINKED THE NEURON 070. THEREFORE, THE NEURON 070 WAS REMOVED AND A NEW NEURON 070 WAS OPENED; HOWEVER, THE PHYSICIAN WAS UNABLE TO ACCESS THE CELIAC TRUNK WITH THIS SYSTEM BECAUSE OF THE TORTUOSITY OF THE PATIENT. THE NEURON 070 SYSTEM WAS REMOVED AND A NON-PENUMBRA SELECT CATHETER WAS USED TO SELECT THE CELIAC AND ACCESS THE DISTAL PART OF THE VESSEL WITH A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER THAT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL INTO THE TARGET VESSEL. WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE TWO NEW RUBY COILS OUT OF THE LANTERN AND INTO THE TARGET VESSEL, BOTH COILS WERE VERY STIFF TO ADVANCE AND RESISTANCE WAS MET. THEREFORE, THE PHYSICIAN SUCCESSFULLY REMOVED BOTH COILS AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675671 ↗
• MalfunctionApr 8, 2016Kinked; 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 NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS KINKED. THE KINKED NEURON 070 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 5563490 ↗

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,