Benchmark BMK6F105BER130-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815948025226), received between Oct 30, 2023 and Feb 12, 2026 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Fracture

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER (5F SELECT), AND A SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE AORTA, THE BENCHMARK FRACTURED AT THE MID-SHAFT. THE FRACTURE OCCURRED WITHIN THE SHEATH. SUBSEQUENTLY, THE SHEATH AND FRACTURED BENCHMARK WAS REMOVED AS A SYSTEM. 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 24327222 ↗
• InjuryJan 23, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHEATH (6F). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO A SMALLER BRANCH OF THE RIGHT RADIAL ARTERY VIA RIGHT RADIAL ACCESS, THE BENCHMARK BECAME STUCK. WHILE RETRACTING THE BENCHMARK, THE BENCHMARK FRACTURED IN HALF. NO ATTEMPTS WERE MADE TO REMOVE THE FRACTURED SEGMENT OF THE BENCHMARK. THE PHYSICIAN THEN GAINED FEMORAL ACCESS AND TREATED BOTH SIDES OF THE MMA. THE FRACTURED SEGMENT OF THE BENCHMARK WAS LEFT IN THE PATIENT¿S ARM. THE PHYSICIAN CURRENTLY HAS NO PLANS FOR REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24166060 ↗
• DeathFeb 26, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN WAS WITHDRAWING THE BENCHMARK AND FELT RESISTANCE. THE PHYSICIAN CONTINUED TO PULL THE BENCHMARK CAUSING IT TO STRETCH AND FRACTURE APPROXIMATELY 30CM FROM THE HUB. AN OPEN SURGERY WAS PERFORMED TO REMOVE THE REMAINING PORTION OF THE BENCHMARK FROM THE ILIAC/AORTA/VERTEBRAL ARTERY. AFTER THE SURGERY, THE PATIENT WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2025 DUE TO COMPLICATIONS OF THE PROCEDURE AND A BRAIN HEMORRHAGE. THE PHYSICIAN ATTRIBUTED THE PROCEDURAL COMPLICATIONS RESULTING IN PATIENT EXPIRATION TO THE FRACTURED BENCHMARK.

  Patient problems: Insufficient Information

  MAUDE report 21473365 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA GUIDE SHEATH AND A MICROCATHETER. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE BENCHMARK THROUGH THE GUIDE SHEATH BY GAINING TRANSRADIAL ACCESS. WHILE ATTEMPTING TO ADJUST THE BENCHMARK, THE PHYSICIAN PULLED THE BENCHMARK BACK. WHILE RETRACTING THE BENCHMARK FURTHER, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE BENCHMARK HAD STOPPED RETRACTING AND WAS FRACTURED. THE PHYSICIAN THEN REMOVED THE BENCHMARK AND THE GUIDE SHEATH TOGETHER. UPON REMOVAL, THE GUIDE SHEATH WAS CUT BY THE PHYSICIAN TO VISUALIZE WHERE THE BENCHMARK WAS FRACTURED. IT WAS REPORTED THAT THE BENCHMARK WAS FRACTURED AT THE MID-SHAFT BUT STILL CONNECTED BY THE COIL WINDS. THE PROCEDURE WAS COMPLETED BY GAINING FEMORAL ACCESS WITH A NEW SHEATH AND A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243357 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SELECT CATHETER, A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BENCHMARK IN THE TARGET VESSEL WITH THE GUIDEWIRE AND SELECT CATHETER. UPON REMOVING THE SELECT CATHETER, THE PHYSICIAN NOTICED THAT THE BENCHMARK APPEARED TO BE UNWINDING. THEREFORE, THE PHYSICIAN WAS ABLE TO MANUALLY PULL AND REMOVED THE BENCHMARK SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120372 ↗
• MalfunctionOct 30, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A BALLOON ASSISTED COIL EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE REMOVING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE BENCHMARK. THE PHYSICIAN THEN PULLED OUT THE BENCHMARK THAT WAS STILL CONNECTED BY WIRE. THE BENCHMARK WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN APPLIED PRESSURE WHILE REMOVING THE BENCHMARK. THE PROCEDURE WAS COMPLETED USING ANOTHER BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035920 ↗