Benchmark BMK6F115MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548014104), received between Jan 4, 2018 and Nov 10, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA INTRODUCER SHEATH, AND GUIDEWIRES. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE BENCHMARK THROUGH THE INTRODUCER SHEATH, THE PHYSICIAN FRACTURED THE MID-SHAFT OF THE BENCHMARK. IT WAS REPORTED THAT THE FRACTURED PART OF THE BENCHMARK WAS OUTSIDE THE PATIENT, AND CONTRAST MEDIA WAS LEAKING FROM THE BENCHMARK. 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 18115042 ↗
• MalfunctionAug 4, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING THE BENCHMARK INTO THE LONG SHEATH AND SUBSEQUENTLY, THE DISTAL TIP OF THE BENCHMARK BECAME DAMAGED. THEREFORE, THE BENCHMARK AND CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND ANOTHER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277948 ↗
• MalfunctionJun 19, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE PATIENT, THE BENCHMARK KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10175449 ↗
• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING BENCHMARK DELIVERY CATHETERS (BENCHMARKS). DURING THE PROCEDURE, THE DISTAL END OF A BENCHMARK BECAME KINKED WHILE BEING ADVANCED INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND, THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW BENCHMARK INTO THE NEURON MAX, HOWEVER THE DISTAL END OF THE BENCHMARK FRACTURED WHILE BEING ADVANCED INTO THE NEURON MAX. THE PHYSICIAN THEN SUCCESSFULLY COMPLETED THE PROCEDURE USING A THIRD BENCHMARK WITH 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 8510261 ↗
• MalfunctionMar 8, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHARMACIST NOTICED THAT THE DISTAL TIP OF A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS FLATTENED UPON OPENING OF 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 ANOTHER BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8404445 ↗
• MalfunctionOct 9, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A BENCHMARK INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AND JUST THE TIP OF THE BENCHMARK WOULD ONLY ADVANCE INTO THE NEURON MAX; THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 7949933 ↗
• MalfunctionJan 4, 2018Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  WHILE PREPARING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) FOR THROMBECTOMY PROCEDURE, THE PHYSICIAN FLUSHED THE BENCHMARK AND NOTICED A LEAK AT THE BASE OF THE PROXIMAL END. THEREFORE, THE BENCHMARK WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7164167 ↗