Benchmark BMK6F95BER120-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00815948025189), received between Sep 18, 2023 and Apr 16, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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.

• MalfunctionApr 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BILATERAL SPHENOPALATINE ARTERY (SPA) THROUGH BILATERAL EXTERNAL CAROTID ARTERY (ECA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA LONG SHEATH (6FR), A COPILOT HEMOSTATIC VALVE, AND A GUIDEWIRE. THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE BENCHMARK FRACTURED WITHIN THE SHEATH. IT WAS REPORTED ALL ACCESS WAS REMOVED INCLUDING THE BENCHMARK FROM THE PATIENT REQUIRING RE-PUNCTURE TO RESTART THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896727 ↗
• InjuryFeb 6, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE SUBCLAVIAN ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PHYSICIAN USED RADIAL ACCESS FOR THE PROCEDURE. AFTER COMPLETION OF THE PROCEDURE, WHILE REMOVING THE BENCHMARK, THE BENCHMARK FRACTURED. THE PROXIMAL PORTION OF THE BENCHMARK WAS REMOVED FROM THE RADIAL ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE REMAINING PORTION OF THE BENCHMARK USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. ON (B)(6) 2026, THE REMAINING PORTION OF THE BENCHMARK WAS REMOVED VIA SURGICAL CUT DOWN USING FEMORAL ACCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24284817 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VENOUS SINUS USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA STENT. WHILE RETRACTING THE BENCHMARK TO PLACE THE STENT IN THE TARGET LOCATION, THE BENCHMARK FRACTURED AT THE DISTAL END. IT WAS REPORTED THAT THE STENT WAS ALSO FRACTURED. THE PROXIMAL END OF THE BENCHMARK WAS REMOVED. A STENT RETRIEVER WAS USED TO SUCCESSFULLY REMOVE THE REMAINING DISTAL SEGMENT OF THE BENCHMARK AND THE FRACTURED PORTION OF THE STENT. IT WAS REPORTED THAT THE REMAINING PORTION OF THE STENT WAS LEFT IN THE VENOUS SINUS. THE PROCEDURE WAS ABORTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839940 ↗
• InjuryNov 13, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHEATH (6F), A NON-PENUMBRA BALLOON CATHETER (0.014" 4MM X 40MM 142CM), AND A GUIDEWIRE (0.035 250CM). IT WAS REPORTED THAT THERE WAS STENOSIS IN THE ICA. THE PHYSICIAN GAINED TRANS-RADIAL ACCESS USING THE SHEATH. IT WAS NOTED THAT A RADIAL COCKTAIL OF VERAPAMIL AND HEPARIN WAS ADMINISTERED PRIOR TO THE PROCEDURE. THE PHYSICIAN ADVANCED THE BENCHMARK AND THE BALLOON CATHETER THROUGH THE SHEATH TO THE TARGET LOCATION AND PERFORMED BALLOON ANGIOPLASTY. THE BALLOON CATHETER WAS REMOVED. WHILE RETRACTING THE BENCHMARK, RESISTANCE WAS ENCOUNTERED, RESULTING IN A FRACTURE WITHIN THE BRACHIAL ARTERY. A VASOSPASM WAS OBSERVED IN THE SAME VESSEL. NITROGLYCERIN WAS ADMINISTERED TO TREAT THE VASOSPASM; HOWEVER, THE EVENT WAS NOT RESOLVED. THE PHYSICIAN ATTEMPTED TO RETRACT THE BENCHMARK, BUT THE BENCHMARK COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO CUT THE BENCHMARK AT THE RADIAL ACCESS SITE. THE PATIENT WAS TRANSFERRED FOR SURGICAL CUT DOWN. THE BENCHMARK WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED T

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 23543903 ↗
• InjuryFeb 21, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS, AND A SHEATH (6FR) VIA THE RADIAL ARTERY. DURING THE PROCEDURE, THE PHYSICIAN NOTED A VASOSPASM IN THE RADIAL ARTERY, SO HE ADMINISTERED VERAPAMIL, BUT THE VASOSPASM CONTINUED. NEXT, THE PHYSICIAN ATTEMPTED TO REMOVE THE BENCHMARK, HOWEVER DUE TO THE VASOSPASM; THE BENCHMARK STRETCHED AND FRACTURED IN THE ARTERY AROUND THE ELBOW. VASCULAR SURGERY WAS CONSULTED AND REMOVED THE FRACTURED DISTAL TIP VIA SURGICAL CUTDOWN. THE PROCEDURE WAS COMPLETED WITH A NEW BENCHMARK, NEW MICROCATHETER, AND A NEW SHEATH VIA THE FEMORAL ARTERY.

  Patient problems: Vasoconstriction

  MAUDE report 21438723 ↗
• MalfunctionJan 7, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS, AND A GUIDEWIRE. DURING THE PROCEDURE, THE BENCHMARK WAS ADVANCED INTO THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ADVANCED THE MICROCATHETER OVER A GUIDEWIRE AND PLACED FOUR COILS IN THE TARGET LOCATION. AN ANGIOGRAPHY WAS PERFORMED AFTER PLACING THE FOURTH COIL. THE PHYSICIAN REPOSITIONED THE BENCHMARK AND PERFORMED A CONTRAST RUN BUT NOTICED THAT CONTRAST WOULD NOT REACH TO THE DISTAL END OF THE BENCHMARK. IT WAS REPORTED THAT CONTRAST WAS LEAKING OUT FROM THE PROXIMAL END OF THE BENCHMARK. THE PHYSICIAN ATTEMPTED TO REMOVE THE BENCHMARK, BUT EXPERIENCED RESISTANCE, AND NOTICED THE BENCHMARK HAD FRACTURED BY THE HUB. AFTER MAKING FURTHER ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE BENCHMARK. THE BENCHMARK WAS FRACTURED AT MULTIPLE LOCATIONS AND REMAINED CONNECTED BY THE INNER WIRE. ALL SEGMENTS OF THE BENCHMARK WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL NON-PENUMBRA COILS, AND A NON-PENUMBRA GUIDE SHEATH. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097773 ↗
• InjuryJan 7, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A TUMOR EMBOLIZATION PROCEDURE IN THE RIGHT RADIAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NEURON SELECT CATHETER 5F (5F SELECT), AND MIDWAY 43 DELIVERY CATHETER (MIDWAY 43). IT WAS NOTED THAT THE RADIAL ARTERY WAS SMALL. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN REMOVING THE BENCHMARK AND THE BENCHMARK HAD FRACTURED AT THE HUB. IT WAS REPORTED THAT A VASOSPASM HAD OCCURRED IN THE RADIAL ARTERY. THE PHYSICIAN ATTEMPTED TO TREAT THE VASOSPASM USING VERAPAMIL, NITROGLYCERIN, NITROPASTE, AND WARM COMPRESSES. THE PHYSICIAN THEN ADVANCED A 5F SELECT INTO THE BENCHMARK TO PROVIDE SUPPORT AND PULLED BACK ON THE BENCHMARK UNTIL THE BENCHMARK COULD NO LONGER BE RETRACTED. THEREFORE, THE PHYSICIAN MANUALLY CUT THE BENCHMARK AND 5F SELECT AT DIFFERENT LOCATIONS USING SURGICAL SCISSORS TO REMOVE FROM THE PATIENT. AFTER SEVERAL ATTEMPTS OF TRYING TO REMOVE THE FRACTURED SEGMENT OUT FROM THE PATIENT, THE PHYSICIAN ACCESSED THE FEMORAL ARTERY AND USED A SNARE DEVICE TO REMOVE THE FRACTURED BENCHMARK SEGMENT OUT FROM THE VESSEL. ALL SEGMENTS OF THE BENCHMARK WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE HAD ENDED AT THI

  Patient problems: Vasoconstriction

  MAUDE report 21088495 ↗
• InjuryOct 24, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHORT SHEATH (6F), AND A GUIDEWIRE. DURING THE PROCEDURE, A SHORT SHEATH WAS PLACED IN THE RADIAL ARTERY AND MEDICATION WAS ADMINISTERED. WHILE ADVANCING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE. AN ANGIOGRAM WAS PERFORMED AND REVEALED THAT THE RADIAL ARTERY WAS VERY SMALL. THE PHYSICIAN ATTEMPTED TO ADVANCE THE BENCHMARK FURTHER WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK FROM THE PATIENT. IT WAS REPORTED THAT THE BENCHMARK WAS STUCK IN THE VESSEL. WHILE ATTEMPTING TO REMOVE THE BENCHMARK, THE DISTAL THIRD OF THE BENCHMARK FRACTURED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A SURGICAL CUT DOWN WAS PERFORMED TO REMOVE THE DISTAL FRACTURED SEGMENT OF THE BENCHMARK. THE PROCEDURE WAS COMPLETED VIA FEMORAL ACCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20523709 ↗
• InjuryJan 19, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK DELIVERY 6F 071 CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH (6F SHORT), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, AND THE ARTERIES WERE NARROW. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE TARGET VESSEL WITH NON-PENUMBRA CATHETERS. NEXT, WHILE ADVANCING A BENCHMARK OVER A 5F SELECT THROUGH THE COMMON CAROTID ARTERY TO THE MCA, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE BENCHMARK BECAME STUCK. WHEN ATTEMPTING TO REMOVE THE BENCHMARK, THE PHYSICIAN FOUND IT WOULD NOT RETRACT AND ONE TO ONE MOVEMENT WAS LOST. IT WAS REPORTED THAT A VASOSPASM OCCURRED IN THE VESSEL AND THE PATIENT WAS GIVEN NITROGLYCERIN AND VERAPAMIL. THE PHYSICIAN ATTEMPTED TO REMOVE THE BENCHMARK A THIRD TIME, AND, SUBSEQUENTLY, FRACTURED THE BENCHMARK MID-SHAFT. THE PROXIMAL PORTION OF THE BENCHMARK WAS REMOVED, AND THE FRACTURED DISTAL PORTION OF THE BENCHMARK REMAINED IN THE PATIENT¿S VESSEL. IT WAS REPORTED THE 5F SELECT WAS STUCK IN THE PROXIMAL PORTION OF THE BENCHMARK. THE PHYSICIAN ATTEMPTED TO REMOVE THE DIST

  Patient problems: Foreign Body In Patient

  MAUDE report 18548386 ↗
• MalfunctionJan 16, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE EXTERNAL CAROTID ARTERY USING A BENCHMARK DELIVERY 6F 071 CATHETER (BENCHMARK) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE BENCHMARK WAS FRACTURED AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517817 ↗
• MalfunctionSep 18, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT EXTERNAL CAROTID ARTERY (ECA) USING A BENCHMARK DELIVERY 6F 071 CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE USING THE MICROCATHETER AND THE GUIDEWIRE TO NAVIGATE TO THE TARGET LOCATION, THE PHYSICIAN NOTICED A LEAK IN THE BENCHMARK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE REMOVING THE BENCHMARK WITH THE 5F SELECT INSIDE, THE BENCHMARK FRACTURED APPROXIMATELY 5-10CM FROM THE HUB. THEREFORE, THE BENCHMARK WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS REPORTED THAT THE BENCHMARK REMAINED INTACT BY A STRAND OF COIL AND WAS REMOVED COMPLETELY. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, NEW 5F SELECT, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17768091 ↗