Benchmark BMK6F105Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548014012), received between Mar 16, 2017 and Sep 5, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA LONG SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK THROUGH THE LONG SHEATH, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE MARKERBAND OF THE BENCHMARK FRACTURED WITHIN THE LONG SHEATH AND MIGRATED INTO THE MIDDLE CEREBRAL ARTERY (MCA). THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN DECIDED NOT TO REMOVE THE MARKER BAND FROM THE MCA SINCE IT WAS NOT OBSTRUCTING THE FLOW. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME LONG SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 22984093 ↗
• MalfunctionNov 6, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK IN THE PATIENT AND THEN NOTICED THAT THE PROXIMAL END OF THE BENCHMARK WAS LEAKING. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THAT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074773 ↗
• MalfunctionApr 19, 2023Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA MICRO-GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE COILS IN THE TARGET VESSEL. WHILE PERFORMING A SERIES OF CONTRAST RUNS, THE PHYSICIAN NOTICED THAT ONLY A SMALL AMOUNT OF THE CONTRAST CAME OUT THE BENCHMARK AND THE IMAGING WAS A LITTLE LESS CLOUDY THAN USUAL. THE PHYSICIAN SUSPECTED A LEAK AND DECIDED TO REMOVE THE BENCHMARK. SUBSEQUENTLY, WHILE RETRACTING THE BENCHMARK, THE DISTAL END OF THE BENCHMARK FRACTURED AND UNRAVELED IN THE BRACHIAL ARTERY. THEREFORE, A VASCULAR SURGEON PERFORMED A SURGICAL CUT DOWN TO RETRIEVE THE FRACTURED DISTAL END OF THE BENCHMARK FROM THE BRACHIAL ARTERY. IT WAS ALSO REPORTED THAT THE BENCHMARK MIGHT HAVE BEEN DAMAGED AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773196 ↗
• MalfunctionDec 30, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHEATH, AN ANGIO-CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE BENCHMARK WAS ADVANCED THROUGH A SHEATH AND RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE BENCHMARK THROUGH THE AORTA. WHILE REMOVING THE BENCHMARK, THE PHYSICIAN INADVERTENTLY BROKE THE BENCHMARK AT THE PROXIMAL END WHILE RETRACTING IT THROUGH THE HUB OF THE SHEATH. HOWEVER, THE BENCHMARK REMAINED INTACT AND WAS COMPLETELY REMOVED FROM THE PATIENT BY HAND. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080683 ↗
• MalfunctionNov 19, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE MICROCATHETER INTO THE BENCHMARK, THE BENCHMARK BROKE INTO TWO PIECES APPROXIMATELY TEN CENTIMETERS FROM THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED.THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA GUIDE CATHETER AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849349 ↗
• MalfunctionOct 22, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) TO TREAT TWO ANEURYSMS USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA FEMORAL SHEATH AND GUIDEWIRES. DURING THE PROCEDURE, AFTER THE PHYSICIAN PERFORMED A DIAGNOSTIC ANGIOGRAPHY, THE PHYSICIAN POSITIONED THE BENCHMARK IN THE CERVICAL INTERNAL CAROTID ARTERY USING A GUIDEWIRE. THE PHYSICIAN ADVANCED THE MICROCATHETER OVER A GUIDEWIRE TO THE ANTERIOR CEREBRAL ARTERY. THE PHYSICIAN THEN PLANNED TO POSITION THE BENCHMARK DISTALLY IN THE INTERNAL CAROTID ARTERY WITH THE HELP OF THE MICROCATHETER AND GUIDEWIRE. ONCE THE PHYSICIAN REACHED THE CAROTID BIFURCATION WITH THE MICROCATHETER AND MICROWIRE, THE PHYSICIAN ATTEMPTED TO POSITION THE BENCHMARK DISTALLY IN THE INTERNAL CAROTID ARTERY. HOWEVER, THE PHYSICIAN NOTICED THAT THE BENCHMARK WAS NO LONGER VISIBLE VIA FLUOROSCOPY. THE PHYSICIAN NOTICED THAT THE BENCHMARK HAD BROKEN WITH THE DISTAL END OF THE BENCHMARK IN THE CAROTID AND THE OTHER PART OF THE BENCHMARK IN THE AORTIC ARCH. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER BUT NOTICED THAT THE MICROCATHETER WAS STUCK INSIDE THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685261 ↗
• MalfunctionApr 3, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), THE PHYSICIAN FOUND THAT THE BENCHMARK WAS BROKEN IN HALF, MID-SHAFT, UPON REMOVAL FROM THE PACKAGING. 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 8477935 ↗
• MalfunctionMar 16, 2017Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK DC THROUGH THE ACCESS SHEATH WITHOUT ANY RESISTANCE. WHILE FLUSHING THE BENCHMARK DC, THE PHYSICIAN FOUND A LEAK AT THE PROXIMAL END OF THE BENCHMARK DC. THEREFORE, THE BENCHMARK DC WAS REMOVED AND 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 6409367 ↗