Benchmark BMK6F95MBER120-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948025202), received between Jan 8, 2024 and Mar 13, 2026 — classified as 4 malfunctions.

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

• MalfunctionMar 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH (6F), NON-PENUMBRA COILS, AND LIQUID EMBOLIC AGENTS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR OR FIVE COILS IN THE TARGET LOCATION. UPON REMOVAL OF THE MICROCATHETER AND BENCHMARK, THE PHYSICIAN FOUND THAT THE BENCHMARK HAD FRACTURED MID-SHAFT. IT WAS NOTED THAT THE FRACTURED SEGMENT OF THE BENCHMARK WAS WITHIN THE AORTA. THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FRACTURED SEGMENT OF THE BENCHMARK FROM THE PATIENT. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592241 ↗
• MalfunctionFeb 7, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN NOTICED THAT THE BENCHMARK FRACTURED. THEREFORE, THE 5F SELECT AND PROXIMAL PORTION 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 HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339825 ↗
• MalfunctionFeb 12, 2024Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE LEFT COMMON CAROTID USING A NON-PENUMBRA CATHETER THROUGH THE BENCHMARK. AFTER GAINING ACCESS, THE PHYSICIAN REMOVED THE NON-PENUMBRA CATHETER AND NOTICED THAT BLOOD WAS LEAKING NEAR THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689175 ↗
• MalfunctionJan 8, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NON-PENUMBRA COILS. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY HAS VERTEBRAL ARTERY STENOSIS. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE COIL IN THE TARGET LOCATION. WHILE ADVANCING ANOTHER COIL THROUGH THE BENCHMARK, THE PHYSICIAN NOTICED THE BENCHMARK WAS KINKED AT THE PROXIMAL END. IT WAS REPORTED THERE WAS A LEAK WHERE THE KINK HAD OCCURRED. THEREFORE, THE BENCHMARK WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469812 ↗