Benchmark BMK6F115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548014098), received between May 10, 2023 and Apr 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Fracture; Unraveled Material; Physical Resistance/Sticking; Fracture; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE BENCHMARK WOULD NOT ADVANCE FURTHER. THE PHYSICIAN THEN OBSERVED UNDER FLUOROSCOPY THAT THE DISTAL LENGTH OF THE BENCHMARK HAD UNRAVELED. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105399 ↗
• MalfunctionMay 10, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, WHILE FLUSHING THE BENCHMARK WITH SALINE, THE PHYSICIAN NOTICED THAT THERE WAS A HOLE NEAR THE HUB OF THE BENCHMARK, OUTSIDE THE PATIENT. 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 16903634 ↗