Benchmark MAX System BMX9690BER125-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00815948022645), received between Dec 21, 2020 and Mar 14, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 11 most recent of 11 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 18909266 ↗
• MalfunctionAug 24, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE COMMON CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA SHEATH (8F), AND A GUIDEWIRE. IT WAS REPORTED THE PATIENT''S ANATOMY WAS TORTUOUS AND THE PHYSICIAN HAD DIFFICULTY ACCESSING THE VESSEL USING THE BMX96. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BMX96 OVER THE 6F SELECT TO THE TARGET LOCATION AGAINST RESISTANCE. WHILE RETRACTING THE 6F SELECT FROM THE BMX96, THE PHYSICIAN EXPERIENCED RESISTANCE, AND NOTICED UNDER FLUOROSCOPY THE BMX96 APPEARED TO BE FRACTURED NEAR THE DISTAL END. THEREFORE, THE PHYSICIAN PULLED OUT THE PROXIMAL PORTION OF THE BMX96 FROM THE PATIENT AND THE DISTAL PORTION WAS REMOVED VIA VASCULAR SURGERY. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED PULLING OUT THE PROXIMAL PORTION OF THE BMX96 FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620129 ↗
• MalfunctionJul 3, 2023Break; Difficult to Advance; Physical Resistance/Sticking; Break; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE BMX96 THROUGH THE RIGHT RADIAL ARTERY. IT WAS REPORTED THAT THE PHYSICIAN CONTINUED TO ADVANCE THE BMX96 AGAINST RESISTANCE AND WAS ABLE TO GET THE BMX96 INTO THE AORTIC ARCH. SUBSEQUENTLY, THE BMX96 WOULD NOT ADVANCE ANY FURTHER AND THE PHYSICIAN DECIDED TO ABORT THE RADIAL ACCESS AND REMOVE THE BMX96. WHILE RETRACTING THE BMX96, THE PHYSICIAN AGAIN EXPERIENCED RESISTANCE AND FRACTURED THE PROXIMAL END OF THE BMX96. THEREFORE, THE PHYSICIAN USED A CLAMP TO REMOVE THE REMAINING EXPOSED BMX96 AND UPON PULLING IT FURTHER, THE DISTAL END OF THE BMX96 HAD BROKEN INTO TWO SEPARATE PIECES. THE PHYSICIAN THEN OBTAINED FEMORAL ACCESS AND USED A SNARE DEVICE TO REMOVE THE BROKEN DISTAL END OF THE BMX96. 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 17252277 ↗
• MalfunctionJun 30, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 6F (6F SELECT) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE BMX96 WAS ADVANCED IN THE RIGHT GROIN USING THE DILATOR AND THE DILATOR WAS REMOVED. WHILE INSERTING THE 6F SELECT INTO THE BMX96, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE 6F SELECT BECAME STUCK AND WOULD NOT ADVANCE THROUGH THE BMX96. WHILE ATTEMPTING TO REMOVE THE 6F SELECT, THE PHYSICIAN NOTICED THE 6F SELECT TO BE BROKEN INSIDE THE BMX96. THEREFORE, THE 6F SELECT WAS REMOVED BY PULLING THE BMX96 OUT. IT WAS REPORTED THAT THE BMX96 WAS NOTICED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING A NEW 6F SELECT AND A NEW BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241719 ↗
• MalfunctionApr 28, 2023Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA SHEATH, A NON-PENUMBRA CATHETER (VTK), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SHEATH THROUGH THE COMMON FEMORAL ARTERY (CFA) TO THE THORACIC AORTA. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. NEXT, A GUIDEWIRE ALONG WITH THE CATHETER WAS ADVANCED TO THE LEFT CAROTID ARTERY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE BMX96 OVER THE CATHETER; SUBSEQUENTLY, A KINK AND A SMALL HOLE WAS NOTICED ON THE PROXIMAL END OF THE BMX96. THEREFORE, THE BMX96 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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 16834765 ↗
• MalfunctionApr 20, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN M2 OCCLUSION OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). AFTER APPROXIMATELY HALFWAY INTO THE PROCEDURE USING THE RED62 AND VELOCITY, THE PHYSICIAN NOTICED THE PROXIMAL END OF THE BMX96 HAD FRACTURED. THE PHYSICIAN CONTINUED AND SUCCESSFULLY COMPLETED THE PROCEDURE USING THE RED62 AND VELOCITY. AFTERWARDS, THE PHYSICIAN REMOVED THE RED62, VELOCITY, AND BMX96 AND NOTICED A MINOR HEMATOMA HAD OCCURRED AT THE PROXIMAL FEMORAL ARTERY. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) TO RECOVER.

  Patient problems: Hematoma

  MAUDE report 16778808 ↗
• MalfunctionMar 21, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), MIDDLE CEREBRAL ARTERY (MCA), AND ANTERIOR CEREBRAL ARTERY (ACA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), NEURON SELECT CATHETER 6F (6F SELECT), AND A NON-PENUMBRA MICROCATHETER. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, WHILE ADVANCING THE BMX96 CONTAINING THE 6F SELECT INTO THE ORIGIN OF THE LEFT VERTEBRAL ARTERY TO PERFORM AN ANGIOGRAM OF THE POSTERIOR ANATOMY, THE DISTAL END OF THE 6F SELECT BROKE OFF IN THE SUBCLAVIAN ARTERY AND WAS STUCK. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS THEN TAKEN TO SURGERY TO REMOVE THE REMAINING BROKEN DISTAL END OF THE 6F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588488 ↗
• MalfunctionMar 21, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND AN 8F NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE RIGHT GROIN USING THE BMX96 AND HAD DIFFICULTY ADVANCING THE BMX96. IT WAS REPORTED THAT THE PHYSICIAN WAS TORQUING THE BMX96 WITH RESISTANCE WHILE ADVANCING. SUBSEQUENTLY, THE PHYSICIAN BROKE THE BMX96 IN HALF INTO TWO SEPARATE PIECES. THE HOSPITAL TECHNOLOGIST HELD PRESSURE ON THE RIGHT GROIN AND THE PHYSICIAN ACCESSED THE LEFT GROIN USING AN 8F SHEATH AND A NEW BMX96. THE PROCEDURE WAS COMPLETED USING A NEW BMX96, RED62, VELOCITY, AND SHEATH. THE PATIENT WAS THEN TAKEN INTO OR AND THE BROKEN BMX96 WAS REMOVED VIA OPEN SURGERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588459 ↗
• MalfunctionNov 11, 2021Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A JET7 OVER A VELOCITY THROUGH THE BENCHMARK MAX TO THE FACE OF THE CLOT AND THEN REMOVED VELOCITY. THE PHYSICIAN CONNECTED THE JET7 TO THE ENGINE AND INITIATED ASPIRATION. AFTER THREE MINUTES UNDER ASPIRATION, THE PHYSICIAN DECIDED TO REMOVE THE JET7. WHILE PULLING BACK THE JET7, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE JET7 WAS NOT MOVING. IT WAS REPORTED THAT THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE. AFTER THE REMOVAL OF THE JET7, IT WAS OBSERVED THAT THE JET7 HAD FRACTURED. ATTEMPTS TO REMOVE THE FRACTURED JET7 SEGMENT USING A SNARE DEVICE WERE UNSUCCESSFUL BECAUSE THE BROKEN DISTAL END OF THE JET7 HAD PROLAPSED INTO THE EXTERNAL CAROTID ARTERY. DAMAGE TO THE DISTAL TIP OF THE BENCHMARK MAX WAS OBSERVED UPON REMOVAL. OPEN SURGERY WAS PERFORMED VIA CAROTID CUTDOWN TECHNIQUE TO SUCCESSFULLY REMOVE THE FRACTURED JET7. THE PROCEDURE WAS THEN COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800111 ↗
• MalfunctionFeb 9, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). DURING THE PROCEDURE, THE HEMOSTASIS VALVE ADAPTER (HVA) WOULD NOT STAY ON THE PROXIMAL THREADED END OF THE BENCHMARK MAX. THEREFORE, THE HVA WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. 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 11304343 ↗
• MalfunctionDec 21, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE ADAPT TECHNIQUE WITH THE JET7 AND BENCHMARK MAX. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO INJECT CONTRAST THROUGH THE BENCHMARK MAX FOR AN ANGIOGRAPHIC RUN WITH THE JET7 IN PLACE; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE JET7 WAS REMOVED. IT WAS REPORTED THERE WAS NO DAMAGE ON THE JET7. A RUN WAS PERFORMED THROUGH THE BENCHMARK MAX WITHOUT A CATHETER INSIDE. THE PHYSICIAN THEN INSERTED A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) TO COMPLETE ANOTHER PASS AND, SUBSEQUENTLY, THE PHYSICIAN WAS ABLE TO INJECT CONTRAST THROUGH THE SAME BENCHMARK MAX WITH THE JETD. THE PROCEDURE ENDED AT THIS POINT RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3. 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 11049555 ↗