Benchmark MAX System BMX9690MSIM125-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948022683), received between Nov 25, 2020 and May 27, 2025 — classified as 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT COMMON CAROTID ARTERY (CCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 AND THE GUIDEWIRE INTO THE RIGHT CCA. THE BMX96 WAS TORQUED IN THE COMMON ILIAC ARTERY AND BECAME DAMAGED. THE PHYSICIAN WAS UNABLE TO ADVANCE A GUIDEWIRE THROUGH THE BMX96. THE BMX96 THEN FRACTURED UPON RETRACTION BUT WAS STUCK IN THE SHEATH. THE PHYSICIAN THEN DECIDED TO REMOVE THE BMX96 AND THE SHEATH TOGETHER FROM THE PATIENT. THE PHYSICIAN CLAMPED THE BMX96 UPON REMOVING IT WITH THE SHEATH AND MADE ANOTHER FRACTURE IN ORDER TO MAINTAIN WIRE ACCESS. THE PROCEDURE WAS COMPLETED USING A NEW BMX96 AND A NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092256 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 INTO THE AORTIC ARCH. WHILE PERFORMING AN INJECTION, THE PHYSICIAN FRACTURED THE BMX96 AT THE HUB. THEREFORE, THE BMX96 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138525 ↗
• MalfunctionNov 25, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ASPIRATE THROUGH THE BENCHMARK MAX WITH A 10CC SYRINGE BUT WAS UNABLE TO ASPIRATE FLUID. THEREFORE, THE PHYSICIAN DID NOT ATTEMPT TO INJECT CONTRAST THROUGH THE BENCHMARK MAX AROUND THE JET7. THE JET7 WAS SUBSEQUENTLY REMOVED. UPON REMOVAL, THE DISTAL END OF THE JET7 WAS OBSERVED TO BE KINKED. THE PROCEDURE ENDED AT THIS POINT. A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS ACHIEVED WITH TWO PASSES USING THE JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10907083 ↗