Benchmark BMK6F95Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00814548014111), received between Dec 7, 2017 and Jun 6, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA CATHETER, A NON-PENUMBRA INTRODUCER SHEATH AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK OVER THE GUIDEWIRE THROUGH THE INTRODUCER SHEATH TO THE RIGHT CAROTID ARTERY VIA THE RIGHT FEMORAL ARTERY. NEXT, THE CATHETER WAS ADVANCED AND PLACED DISTAL TO THE ANEURYSM. THE PHYSICIAN THEN SUCCESSFULLY PLACED ALL THE COILS NEEDED IN THE ANEURYSM. AFTERWARDS, THE CATHETER WAS REMOVED. A CONTRAST MEDIA WAS THEN PERFORMED AND A LACK OF CONTRAST IN THE TARGET VESSEL WAS NOTICED. THE PHYSICIAN THEN DECIDED TO REMOVE THE BENCHMARK. WHILE REMOVING THE BENCHMARK FROM THE INTRODUCER SHEATH, ONLY THE PROXIMAL END OF THE BENCHMARK WAS REMOVED. SUBSEQUENTLY, UNDER FLUOROSCOPY IT WAS NOTICED THAT THE BENCHMARK HAD FRACTURED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DISTAL SEGMENT OF THE BENCHMARK. 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 17068485 ↗
• MalfunctionNov 4, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, AND A 6F NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE BENCHMARK AND THEN INSERTED IT INTO THE SHORT SHEATH WHEN THE PHYSICIAN NOTICED THE BENCHMARK STARTED TO LEAK AT THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME SHEATH. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727617 ↗
• InjuryFeb 22, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE TO TREAT A RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NEURON SELECT CATHETER 5F (5F SELECT), TWO NON-PENUMBRA MICROCATHETERS, A NON-PENUMBRA EMBOLIZATION DEVICE AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BENCHMARK VIA RADIAL ACCESS WITH NO ISSUE AND DELIVERED THE EMBOLIZATION DEVICE WITH THE MICROCATHETERS INSIDE THE BENCHMARK. WHILE PERFORMING ANGIOGRAPHY, THE PHYSICIAN NOTICED AIR ENTERING THE SYRINGE PRIOR TO INJECTING THE CONTRAST INTO THE BENCHMARK. THEREFORE, THE PHYSICIAN EXCHANGED THE BENCHMARK WITH A NEW BENCHMARK; HOWEVER, THE SAME ISSUE WAS OBSERVED. IT WAS REPORTED THAT THE TWO BENCHMARKS WERE CRACKED AND LEAKING NEAR THE HUB. THEN, A THIRD BENCHMARK WAS OPENED TO CONTINUE WITH THE PROCEDURE. WHILE ATTEMPTING TO ADVANCE THE MICROCATHETERS INTO THE THIRD BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE MICROCATHETERS COULD NOT BE ADVANCED. NEXT, THE PHYSICIAN EXCHANGED THE GUIDEWIRE AND WHEN THE PHYSICIAN PULLED THE BENCHMARK FROM THE PATIENT'S ARM, THE BENCHMARK BROKE APPROXIMATELY 10 CENTIMETERS FROM THE HUB AND THE REMAINING DISTAL S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578360 ↗
• MalfunctionJan 15, 2021Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND NEURON SELECT 5F CATHETER (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK TO THE TARGET VESSEL WITH THE 5F SELECT, THE BENCHMARK STARTING LEAKING NEAR THE HUB. THEREFORE, THE BENCHMARK WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 11177074 ↗
• MalfunctionAug 15, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK TO THE TARGET VESSEL USING A GUIDEWIRE AND A SELECT CATHETER FOR ACCESS. APPROXIMATELY ONE HOUR INTO THE PROCEDURE USING THE BENCHMARK AND A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED A HOLE NEAR THE HUB OF THE BENCHMARK AND IT WAS LEAKING WITH SALINE; THEREFORE, THE BENCHMARK WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897606 ↗
• MalfunctionApr 25, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNOLOGIST FOUND THE HUB OF THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) TO BE BROKEN UPON OPENING THE PACKAGING. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8549083 ↗
• MalfunctionFeb 21, 2019Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FLUSHED A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) ON THE BACK TABLE AND FOUND THAT IT WAS LEAKING SALINE FROM THE PROXIMAL END OF THE BENCHMARK. IT WAS REPORTED THAT THE BENCHMARK APPEARED KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8357367 ↗
• MalfunctionDec 20, 2018Break; Break

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN REMOVED A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) FROM ITS PACKAGING TUBE AND LAID IT DOWN ON THE SCRUB TABLE. HOWEVER, WHEN THE PHYSICIAN WENT TO FLUSH IT, IT WAS DISCOVERED THAT THE BENCHMARK WAS BROKEN IN TWO PIECES AND THE METAL WINDING HOLDING THE TWO PIECES TOGETHER WAS EXPOSED. THE DAMAGE TO THE BENCHMARK OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8187194 ↗
• MalfunctionDec 19, 2018Break; Unraveled Material; Break; Unraveled Material

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN REMOVED A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) FROM ITS PACKAGING TUBE AND FLUSHED IT. HOWEVER, THE BENCHMARK THEN BROKE AND UNRAVELED. THE DAMAGE TO THE BENCHMARK OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 8182828 ↗
• MalfunctionMay 18, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP OF THE BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE. THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. IT WAS NOTED THAT THE PACKAGING ITSELF DID NOT SHOW ANY DAMAGES. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7527573 ↗
• MalfunctionMay 1, 2018Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE NURSE REMOVED A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) FROM THE PACKAGING AND FLUSHED IT. THE BENCHMARK WAS THEN ATTACHED TO A ROTATING HEMOSTASIS VALVE (RHV) AND READY TO USE WITH NO NOTED ISSUE. HOWEVER, WHEN COMMENCING CONTINUOUS FLUSH THROUGH THE BENCHMARK, THE PHYSICIAN NOTICED THAT THE BENCHMARK WAS LEAKING AROUND THE HUB. THEREFORE, THE BENCHMARK WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7476947 ↗
• MalfunctionDec 7, 2017Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WAS SNAPPED IN HALF UPON REMOVAL FROM THE DISPENSER HOOP. THE DAMAGED BENCHMARK WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK.

  Patient problems: No Patient Involvement

  MAUDE report 7095548 ↗