Benchmark BMK6F95MRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548014166), received between Sep 24, 2015 and Mar 30, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (6 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). THE PHYSICIAN INSERTED THE BENCHMARK VIA TRANSRADIAL ACCESS AND OBSERVED VASOSPASMS. WHILE ATTEMPTING TO REMOVE THE BENCHMARK, THE PHYSICIAN EXPERIENCED DIFFICULTY AND FOUND THAT THE BENCHMARK FRACTURED IN THE BRACHIAL ARTERY. THE FRACTURED BENCHMARK WAS REMOVED VIA TRANSFEMORAL ACCESS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX).NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED.

  Patient problems: Vasoconstriction

  MAUDE report 24719417 ↗
• MalfunctionMar 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A SHEATH, COILS, A FLOW DIVERTER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE BENCHMARK IN THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). UPON REMOVAL AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE BENCHMARK WAS FRACTURED AND THE PROXIMAL THIRD WAS RETRIEVED. THE PHYSICIAN THEN GAINED ACCESS IN THE OPPOSITE FEMORAL ARTERY AND USED A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT OF THE BENCHMARK. THE PROCEDURE ENDED AT THIS POINT. DUE TO THE PATIENT'S DUAL ANTIPLATELET THERAPY (DAPT), THE PHYSICIAN WAS UNABLE TO USE AN ANGIOSEAL AND INSTEAD APPLIED PROLONGED MANUAL PRESSURE TO THE GROIN. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646803 ↗
• MalfunctionJan 14, 2025Fracture; Failure to Advance; Physical Resistance/Sticking; Fracture; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA 8F INTRODUCER SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK USING ITS PEEL AWAY SHEATH THROUGH THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED DIFFICULTY. AFTER ADVANCING THE BENCHMARK APPROXIMATELY FIFTY CENTIMETERS, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE BENCHMARK STOPPED ADVANCING. THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO REMOVE THE BENCHMARK AND FRACTURED THE BENCHMARK. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE FRACTURED SEGMENT OF THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150396 ↗
• MalfunctionAug 25, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A PIPELINE EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA PIPELINE EMBOLIZATION DEVICE AND A SHEATH. DURING THE PROCEDURE, THE RADIAL ACCESS WAS GAINED, AND THE BENCHMARK WAS ADVANCED. THE PHYSICIAN THEN NOTICED THE HUB OF THE BENCHMARK WAS CRACKED AND AIR WAS GOING INTO THE SYSTEM. THEREFORE, THE BENCHMARK WAS REMOVED, AND A NON-PENUMBRA CATHETER WAS USED. IT WAS REPORTED THAT THE PHYSICIAN ABORTED THE PROCEDURE AFTER THE NON-PENUMBRA PIPELINE EMBOLIZATION DEVICE FAILED TO EXPAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624879 ↗
• MalfunctionJun 6, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A 6F SHORT SHEATH, A 5FR DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHORT SHEATH INTO THE PATIENT. AFTER PERFORMING DIAGNOSTIC ANGIOGRAMS, THE PHYSICIAN ADVANCED THE BENCHMARK TO THE ORIGIN OF THE SUBCLAVIAN ARTERY USING THE GUIDEWIRE. WHILE ADVANCING THE DIAGNOSTIC CATHETER THROUGH THE BENCHMARK, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE DIAGNOSTIC CATHETER WAS PARALLEL TO THE DISTAL END OF THE BENCHMARK. SUBSEQUENTLY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE MID-SHAFT OF THE BENCHMARK WAS FRACTURED IN THE ABDOMINAL AORTA. THEREFORE, THE DIAGNOSTIC CATHETER AND THE PROXIMAL PART OF THE BENCHMARK WERE REMOVED. AFTER A FEW ATTEMPTS, THE PHYSICIAN SUCCESSFULLY REMOVED THE DISTAL PART OF THE BENCHMARK USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, A NEW 6F SHORT SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074184 ↗
• MalfunctionDec 20, 2022Break; Break

  THE PATIENT WAS UNDERGOING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT AN ARTERY SPASM OF THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK IN THE PATIENT. AFTERWARDS, THE PHYSICIAN COULD NOT INJECT CONTRAST VIA THE BENCHMARK; THEREFORE, THE PHYSICIAN CHECKED THE BENCHMARK. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE BENCHMARK WAS LEAKING AT THE MID-SHAFT. THEREFORE, THE BENCHMARK WAS REMOVED. IT WAS REPORTED THAT UPON REMOVAL, A CUT WAS OBSERVED WHERE THE BENCHMARK WAS LEAKING. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018330 ↗
• MalfunctionJul 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA INTRODUCER SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE BENCHMARK INTO THE INTRODUCER SHEATH. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215644 ↗
• MalfunctionMar 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT A BENCHMARK WAS KINKED NEAR THE HUB UPON REMOVAL FROM PACKAGING. HOWEVER, THE PHYSICIAN ATTEMPTED TO STILL USE THE BENCHMARK AND EXPERIENCED RESISTANCE IN THE AREA THAT WAS KINKED. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486278 ↗
• MalfunctionSep 18, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE BENCHMARK THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THEREFORE, THE PHYSICIAN REMOVED THE BENCHMARK AND FOUND THE DISTAL END TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK 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 9082570 ↗
• MalfunctionMay 3, 2019Fluid/Blood Leak; Peeled/Delaminated; Fluid/Blood Leak; Peeled/Delaminated

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), THE PHYSICIAN REMOVED THE BENCHMARK FROM ITS PACKAGING AND BEGAN FLUSHING IT. THE PHYSICIAN THEN REALIZED THAT THE BENCHMARK WAS LEAKING FROM THE HUB. IT WAS ALSO NOTED THAT THE HUB COATING WAS PEELING OFF. THE BENCHMARK WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8579766 ↗
• MalfunctionFeb 13, 2019Difficult to Flush; Difficult to Flush

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), THE HOSPITAL STAFF FOUND A PLASTIC COATING ON THE INSIDE OF THE DISTAL END OF THE BENCHMARK, WHICH PREVENTED IT FROM BEING FLUSHED. THE ISSUE WITH THE BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8338178 ↗
• MalfunctionJan 30, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED UPON OPENING THE PACKAGE. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8288763 ↗
• MalfunctionApr 30, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  WHILE PREPARING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) FOR A MEDICAL PROCEDURE, IT BROKE IN TWO PIECES ABOUT 20CM FROM THE HUB. THE HOSPITAL STAFF ALSO FOUND THAT A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS STUCK ON THE PACKAGING MANDREL AND WHEN THEY REMOVED THE NEURON MAX FROM THE PACKAGING, THE TIP OF THE NEURON MAX WAS RIPPED OFF. THEREFORE, THE BENCHMARK AND THE NEURON MAX WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW BENCHMARK AND NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7474625 ↗
• MalfunctionNov 20, 2017Break; 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, A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS DIFFICULT TO REMOVE FROM ITS PLASTIC PACKAGING. THE PHYSICIAN ATTEMPTED TO REMOVE THE BENCHMARK VERY CAREFULLY FROM ITS PACKAGING, HOWEVER THE BENCHMARK BECAME STUCK, CONSEQUENTLY THE TIP OF THE BENCHMARK BROKE OFF APPROXIMATELY NINE CENTIMETER FROM THE TIP. THE DAMAGE TO THE BENCHMARK OCCURRED PRIOR TO USE AND THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7046536 ↗
• MalfunctionMar 10, 2017Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE RADIOLOGIST NOTICED THAT THE TIP OF THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC) WAS BENT UPON REMOVAL FROM THE PACKAGING. IT WAS REPORTED THAT THE OUTER PACKAGING OF THE DEVICE DID NOT APPEAR TO BE DAMAGED. THE BENT BENCHMARK DC WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK DC.

  Patient problems: No Patient Involvement

  MAUDE report 6397613 ↗
• MalfunctionJul 29, 2016Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE MID SECTION OF THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC) WAS BENT UPON REMOVAL FROM THE PACKAGING. THE BENT BENCHMARK DC WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK DC.

  Patient problems: No Patient Involvement

  MAUDE report 5835061 ↗
• MalfunctionApr 28, 2016Device Damaged Prior to Use; Split; Device Damaged Prior to Use; Split

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED A SPLIT ON THE TIP OF THE BENCHMARK DELIVERY CATHETER (BENCHMARK DC) UPON REMOVAL FROM THE PACKAGING. THE DAMAGED BENCHMARK DC WAS FOUND PRIOR TO USE; THEREFORE, IT WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 5614781 ↗
• MalfunctionDec 17, 2015Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK DELIVERY CATHETER (BENCHMARK DC). DURING THE PROCEDURE THE PHYSICIAN ADVANCED THE BENCHMARK DC IN THE PATIENT AND INJECTED CONTRAST, HOWEVER NOTHING SHOWED UP IN THE PATIENT'S VESSELS. UPON REMOVING THE BENCHMARK DC FROM THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS BROKEN/FRACTURED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK DC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5308198 ↗
• MalfunctionSep 24, 2015Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A BENCHMARK DELIVERY CATHETER (BENCHMARK CATHETER). UPON REMOVAL FROM THE PACKAGING, THE BENCHMARK CATHETER WAS FOUND FRACTURED AND WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 5101642 ↗