Neuron PNS6F125SIMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548012070), received between Dec 22, 2015 and Sep 3, 2021 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT COMMON CAROTID ARTERY USING A NEURON SELECT CATHETER 6F (6F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A 6F SELECT OVER A GUIDEWIRE THROUGH THE NEURON MAX IN THE AORTIC ARCH, THE DISTAL END OF THE 6F SELECT BROKE OFF AND MIGRATED THROUGH THE DESCENDING AORTA TO THE LEFT ILIAC FEMORAL BIFURCATION. THE PHYSICIAN THEN REMOVED THE NEURON MAX AND 6F SELECT. NEXT, THE PHYSICIAN INSERTED A NON-PENUMBRA DIAGNOSTIC CATHETER FOR SELECTIVE CAROTID ACCESS, THEN ADVANCED THE GUIDEWIRE. THE NON-PENUMBRA DIAGNOSTIC CATHETER WAS THEN REMOVED AND THE SAME NEURON MAX WAS POSITIONED IN THE DISTAL RIGHT COMMON CAROTID ARTERY TO PERFORM A COIL EMBOLIZATION USING A NON-PENUMBRA DISTAL ACCESS CATHETER AND A MICROCATHETER. AFTERWARDS, WHILE REMOVING THE BROKEN PIECE OF THE 6F SELECT USING A NON-PENUMBRA LOOP CATHETER IN AN ENDOVASCULAR PROCEDURE, THE BROKEN PIECE OF THE 6F SELECT BROKE INTO THREE PIECES. SUBSEQUENTLY, IT WAS NOTED THAT THE BROKEN PIECES TRAVELED DOWN AND OCCLUDED THE LEFT SUPERFICIAL FEMORAL ARTERY AND DEEP FEMORAL ARTERY. THE BROKEN PIECES OF THE 6F SELECT WERE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422651 ↗
• DeathJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON SELECT CATHETER 6F (6F SELECT). DURING THE PROCEDURE, A MILD CATHETER INDUCED VASOSPASM WAS NOTICED IN THE M1 SEGMENT. THE PHYSICIAN INFUSED 5MG OF VERAPAMIL INTO THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE EVENT WAS CONSIDERED RESOLVED AS OF 24-JUN-2019 WITH THE INFUSION OF VERAPAMIL. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND A DEFINITE RELATIONSHIP TO THE JET7. ON (B)(6) 2019, THE PATIENT HAD A SECOND STROKE IN THE CEREBELLUM CAUSING CEREBRAL EDEMA AND WAS TREATED WITH DECOMPRESSIVE OCCIPITAL CRANIECTOMY. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2019 SHOWED A DECREASE IN MASS EFFECT. THE PATIENT EXPIRED DUE TO ACUTE ISCHEMIC STROKE ON (B)(6) 2019. THE ACUTE ISCHEMIC STROKE WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE 6F SELECT. ON 07-NOV-2019, IT WAS ADJUDICATED THAT THE ACUTE ISCHEMIC STROKE IS UNRELATED TO THE 6F SELEC

  Patient problems: Death; Edema; Infarction, Cerebral

  MAUDE report 8832710 ↗
• MalfunctionMay 2, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE 6F SELECT THROUGH THE MIDDLE OF A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). ALTHOUGH THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT, MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. AS OF (B)(6) 2018, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7479599 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE 6F SELECT INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS REPORTED THAT THE 6F SELECT DID NOT FIT INTO THE NEURON MAX. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER 6F 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 7242797 ↗
• MalfunctionSep 14, 2016Sticking; Difficult to Advance; Mechanical Jam; Sticking; Difficult to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, WHILE ADVANCING A 6F SELECT THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE 6F SELECT WOULDN'T ADVANCE SMOOTHLY THROUGH THE NEURON MAX. THE PHYSICIAN STATED THAT THE 6F SELECT REQUIRED UNUSUAL FORCE TO ADVANCE AND WAS ALMOST IMPOSSIBLE TO TURN AND FELT UNUSUALLY STICKY. THE 6F SELECT WAS FLUSHED BEFORE USE AND AFTER THE INITIAL RECOGNITION OF THE ISSUE. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE IT AND THEREFORE, IT WAS REMOVED. NO VISIBLE DAMAGE WAS OBSERVED ON THE 6F SELECT AFTER REMOVAL. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND OTHER MANUFACTURER'S CATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5951145 ↗
• MalfunctionJun 24, 2016Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F SELECT CATHETER (6F SELECT). DURING THE PROCEDURE, THE 6F SELECT DID NOT FIT THROUGH ANOTHER MANUFACTURER'S BALLOON GUIDING CATHETER. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER SELECTING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5748828 ↗
• MalfunctionJun 9, 2016Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, WHILE ATTACHING THE ROTATING HEMOSTASIS VALVE (RHV) TO A NEURON 6F SELECT CATHETER (6F SELECT), THE HOSPITAL STAFF NOTICED THAT THE 6F SELECT HUB WAS BROKEN. THE BROKEN HUB WAS NOTICED PRIOR TO USE WHILE OUTSIDE OF THE PATIENT; THEREFORE, THE 6F SELECT WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 6F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 5710647 ↗
• MalfunctionDec 23, 2015Out-Of-Box Failure; Defective Device

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP SHAPES OF TWO NEURON SELECT 6F CATHETERS (6F SELECT) DID NOT CORRESPOND TO THE CORRECT SHAPE ON THE LABELING. THE TWO 6F SELECT DEVICES WITH INCORRECT TIP SHAPES WERE FOUND PRIOR TO USE AND WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 5322999 ↗
• MalfunctionDec 22, 2015Structural Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP SHAPES OF TWO NEURON SELECT 6F CATHETERS (6F SELECT) DID NOT CORRESPOND TO THE CORRECT SHAPE ON THE LABELING. THE TWO 6F SELECT DEVICES WITH INCORRECT TIP SHAPES WERE FOUND PRIOR TO USE AND WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 5321640 ↗

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