Benchmark BMK6F105MBER130-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948025240), received between Mar 14, 2024 and Mar 14, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BMX96 ACCESS SYSTEM (BMX96), BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARK), AND GUIDEWIRES. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, AND THE GUIDEWIRES WERE PLACED IN THE PETROUS PORTION OF THE ICA. DURING THE PROCEDURE, WHILE ADVANCING THE BMX96 TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE BMX96. THE PHYSICIAN THEN VISUALIZED UNDER FLUOROSCOPY THAT THE MIDSHAFT OF THE BMX96 WAS FRACTURED; HOWEVER, THE BMX96 WAS STILL INTACT. THEREFORE, THE BMX96 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN DECIDED TO USE A BENCHMARK. WHILE ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE PROXIMAL END OF THE BENCHMARK BECAME UNRAVELED. THEREFORE. THE BENCHMARK WAS REMOVED. A SECOND BENCHMARK WAS ADVANCED INTO THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO REPOSITION THE BENCHMARK. WHILE RETRACTING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PROXIMAL END OF THE BENCHMARK BECAME UNRAVELED. THEREFORE, THE SECOND BENCHMARK WAS REMOVED. IT WAS REPORTED SHEATHS WERE NOT BEING USED AND THAT MAY HAVE CONTRIBUTED TO THE DAM

  Patient problems: Hematoma

  MAUDE report 18909279 ↗
• InjuryMar 14, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BMX96 ACCESS SYSTEM (BMX96), BENCHMARK 6F 071 DELIVERY CATHETERS (BENCHMARK), AND GUIDEWIRES. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, AND THE GUIDEWIRES WERE PLACED IN THE PETROUS PORTION OF THE ICA. DURING THE PROCEDURE, WHILE ADVANCING THE BMX96 TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE BMX96. THE PHYSICIAN THEN VISUALIZED UNDER FLUOROSCOPY THAT THE MIDSHAFT OF THE BMX96 WAS FRACTURED; HOWEVER, THE BMX96 WAS STILL INTACT. THEREFORE, THE BMX96 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN DECIDED TO USE A BENCHMARK. WHILE ADVANCING THE BENCHMARK INTO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE PROXIMAL END OF THE BENCHMARK BECAME UNRAVELED. THEREFORE. THE BENCHMARK WAS REMOVED. A SECOND BENCHMARK WAS ADVANCED INTO THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO REPOSITION THE BENCHMARK. WHILE RETRACTING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PROXIMAL END OF THE BENCHMARK BECAME UNRAVELED. THEREFORE, THE SECOND BENCHMARK WAS REMOVED. IT WAS REPORTED SHEATHS WERE NOT BEING USED AND THAT MAY HAVE CONTRIBUTED TO THE DAM

  Patient problems: Hematoma

  MAUDE report 18909269 ↗