Benchmark BMK6F105-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948025141), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Fracture; Unraveled Material; Physical Resistance/Sticking; Fracture; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INNOMINATE ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA SHEATH (6FR), NON-PENUMBRA GLIDECATH, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT'S ARTERIES WERE SMALL. DURING THE PROCEDURE, A 6F SHEATH WAS PLACED IN THE RADIAL ARTERY AND MEDICATION WAS ADMINISTERED. THE PHYSICIAN OBTAINED CENTRAL ACCESS USING THE GLIDECATH WITH A GUIDEWIRE. THE GUIDEWIRE WAS THEN USED TO EXCHANGE FROM THE GLIDECATH TO A BENCHMARK; HOWEVER, WHILE ADVANCING THE BENCHMARK INTO THE INNOMINATE ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN ATTEMPTED TO RETRACT THE BENCHMARK WITHOUT THE WIRE BUT HAD DIFFICULTY. THE PHYSICIAN THEN ATTEMPTED TO USE A KELLY CLAMP TO REMOVE THE BENCHMARK, BUT THE BENCHMARK HAD FRACTURED AND BEGAN TO UNRAVEL. THE PROXIMAL END OF THE BENCHMARK WAS REMOVED FROM THE SHEATH USING THE KELLY CLAMP. THE PHYSICIAN ACCESSED THE GROIN AND USED A SNARE DEVICE TO REMOVE THE FRACTURED DISTAL END OF THE BENCHMARK FROM THE GROIN. THE PROCEDURE WAS COMPLETED USING NEW DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260807 ↗