Benchmark MAX System BMX9680BER105-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948022638), received between Jul 8, 2021 and Feb 21, 2025 — classified as 1 injury, 3 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.

• MalfunctionFeb 21, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96) AND A NEURON SELECT CATHETER 6F (6F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 6F SELECT CATHETER IN THE CAROTID ARTERY, THE PHYSICIAN NOTICED THE DISTAL LENGTH OF THE 6F SELECT HAD FRACTURED IN THE FEMORAL ARTERY UNDER FLUOROSCOPY. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL PORTION OF THE 6F SELECT OUT FROM THE BMX96. THE PHYSICIAN THEN ADVANCED THE BMX96 FROM THE RIGHT FEMORAL ARTERY TO THE LEFT FEMORAL ARTERY AND USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE FRACTURED 6F SELECT. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND IS RESCHEDULED FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437083 ↗
• InjuryFeb 17, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR/VERTEBRAL ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA ASPIRATION CATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO GAIN FEMORAL ACCESS USING THE BMX96; HOWEVER, FEMORAL ACCESS WAS NOT POSSIBLE. THEREFORE, THE PHYSICIAN DECIDED TO USE RADIAL APPROACH USING THE BMX96. IT WAS REPORTED THAT THE RADIAL ARTERY OF THE PATIENT WAS TIGHT AND WOULD ONLY ACCOMMODATE THE BMX96 UP TO THE BRACHIAL ARTERY SEGMENT. THE PHYSICIAN THEN ADVANCED THE NON-PENUMBRA ASPIRATION CATHETER OVER THE GUIDEWIRE AND THE VELOCITY THROUGH THE BMX96 TO THE VERTEBRAL ARTERY; HOWEVER, THE ASPIRATION CATHETER HAD REACHED THE HUB OF THE BMX96 AT THIS POINT AND WOULD NOT ADVANCE FURTHER TO THE TARGET VESSEL.  THE PHYSICIAN COULD NOT TREAT THE STROKE DUE TO A LACK OF LENGTH IN THE SYSTEM, AND THEREFORE, THE VELOCITY, ASPIRATION CATHETER AND GUIDEWIRE WERE REMOVED. THE PHYSICIAN THEN INSERTED A DIFFERENT GUIDEWIRE TO REMOVE THE BMX96. WHILE ATTEMPTING TO REMOVE THE BMX96, THE PHYSICIAN EXPERIENCED RESISTANCE

  Patient problems: Foreign Body Embolism

  MAUDE report 16400994 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), A NEURON SELECT CATHETER 5F (5F SELECT), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 OVER THE GUIDEWIRE AND 5F SELECT. SUBSEQUENTLY, AFTER 30 MINUTES OF USE AND COMPLETING AN ANGIOGRAM, THE BMX96 WAS NOTICED TO BE LEAKING. THEREFORE, THE BENCHMARK WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN FOUND THE BMX96 TO BE FRACTURED MID-SHAFT. THE PROCEDURE WAS COMPLETED USING A NEW BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439820 ↗
• MalfunctionJul 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), A NEURON SELECT CATHETER 6F (6F SELECT) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE TRACKING A BENCHMARK MAX OVER THE 6F SELECT IN AN ARCH TO THE TARGET VESSEL, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE BENCHMARK MAX APPEARED KINKED AND THE BENCHMARK MAX WOULD NOT ADVANCE. THEREFORE, THE BENCHMARK MAX AND THE 6F SELECT WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE EXACT EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139768 ↗