Benchmark MAX System BMX9690SIM125-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948022652), received between Feb 14, 2021 and Jul 18, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), ANTERIOR CEREBRAL ARTERY (ACA), AND MIDDLE CEREBRAL ARTERY (MCA), USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE BMX96 HAD BROKEN. SUBSEQUENTLY, WHILE ATTEMPTING TO REMOVE THE BMX96, IT BROKE INTO THREE PIECES. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE BROKEN PIECES OF THE BMX96. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347299 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). UPON COMPLETION OF THE PROCEDURE, THE BENCHMARK MAX WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN REPORTED THAT THE VESSEL APPEARED TO BE DAMAGED. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) TO RECOVER. LATER THE SAME DAY, THE PATIENT SUFFERED STROKE-LIKE SYMPTOMS AND SUBSEQUENTLY, A HEAD COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A COMPLETE INFARCT OF THE LEFT HEMISPHERE CAUSED BY A DISSECTION OF THE CERVICAL SECTION OF THE ICA. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR AN EMERGENT HEMI-CRANI PROCEDURE.

  Patient problems: Ischemia Stroke; Vascular Dissection

  MAUDE report 15933963 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), NEURON SELECT CATHETER 5F (5F SELECT), PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK MAX WITH 5F SELECT TO GAIN ACCESS TO THE VESSEL AND PLACED THE BENCHMARK MAX IN THE HIGH CERVICAL. AFTER GAINING AN ACCESS AND PLACING THE BENCHMARK MAX, THE 5F SELECT WAS REMOVED. NEXT, TO PERFORM THROMBECTOMY, THE PHYSICIAN ATTACHED THE RHV AND ADVANCED THE JET7 AND 3MAXC BY USING A GUIDEWIRE THROUGH THE BENCHMARK MAX. WHILE ATTEMPTING TO PASS THE OPHTHALMIC ARTERY, THE BENCHMARK MAX WHICH WAS PLACED IN HIGH CERVICAL STARTED TO PROLAPSE BACK INTO THE AORTIC ARCH. THEREFORE, THE PHYSICIAN APPLIED FORWARD PRESSURE ON THE BENCHMARK MAX TO MOVE IT BACK TO ITS ORIGINAL LOCATION. SUBSEQUENTLY, THE JET7 ALSO MOVED PAST THE OPHTHALMIC ARTERY UP TO THE CLOT AND THE PHYSICIAN WAS ABLE TO PERFORM THE THROMBECTOMY SUCCESSFULLY. UPON COMPLETION OF THE PROCE

  Patient problems: Perforation of Vessels

  MAUDE report 12478334 ↗
• MalfunctionJun 9, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN M1 OCCLUSION USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE VELOCITY AND A GUIDEWIRE TO BRING UP THE BENCHMARK MAX TO THE TARGET VESSEL. WHILE RETRACTING THE VELOCITY OUT OF THE BENCHMARK MAX TO PERFORM ASPIRATION, THE BENCHMARK MAX BROKE AT THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971366 ↗
• MalfunctionFeb 14, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT COMMON CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA GUIDEWIRE, AND NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE SHEATH WAS FIRST INSERTED INTO THE PATIENT; HOWEVER, THE PHYSICIAN DECIDED TO EXCHANGE THE SHEATH FOR A BENCHMARK MAX. SUBSEQUENTLY, WHILE INSERTING THE BENCHMARK MAX OVER A DILATOR TO ACCESS THE RADIAL ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE AND DAMAGED THE DISTAL TIP OF THE BENCHMARK MAX. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A BENCHMARK TO NAVIGATE THE GUIDEWIRE TO THE TARGET VESSEL; HOWEVER, IT WAS UNSUCCESSFUL. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEFICIENCY OR DAMAGE TO THE BENCHMARK. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. 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 11326277 ↗