Benchmark MAX System BMX7F105-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948024601), received between Oct 4, 2024 and Sep 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE COMMON CAROTID ARTERY (CCA) USING A BENCHMARK BMX81 ACCESS SYSTEM (BMX81), A NON-PENUMBRA SHEATH (7F), A NON-PENUMBRA ASPIRATION CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE RADIAL ARTERY USING THE SHEATH. WHILE ADVANCING THE BMX81 THROUGH THE SHEATH OVER THE GUIDEWIRE TOWARD THE SUBCLAVIAN ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS NOTED THAT THE PHYSICIAN WAS ABLE TO ADVANCE THE BMX81 TO THE CCA. THE PHYSICIAN THEN ADVANCED THE ASPIRATION CATHETER THROUGH THE BMX81 OVER THE GUIDEWIRE TO THE TARGET LOCATION AND PERFORMED ASPIRATION. AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED THE ASPIRATION CATHETER. WHILE REMOVING THE BMX81 FROM THE PATIENT'S BODY, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE BMX81 BECAME DAMAGED AT THE MIDSHAFT OUTSIDE OF THE PATIENT'S BODY. THE PHYSICIAN THEN USED A HEMOSTAT TO CLAMP THE BMX81 AND THE SHEATH TOGETHER TO PREVENT AIR FROM ENTERING. WHILE SLOWLY REMOVING THE BMX81 AND THE SHEATH USING THE HEMOSTAT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE RADIAL ARTERY CAME OUT ALONG WITH THE DAMAGED BMX81. THE PHYSICIAN HELD

  Patient problems: Perforation of Vessels

  MAUDE report 23073868 ↗
• MalfunctionOct 4, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING A BENCHMARK BMX81 ACCESS SYSTEM (BMX81) AND A NON-PENUMBRA SHEATH (7FR). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET VESSEL THROUGH THE RIGHT RADIAL ARTERY AND ADMINISTERED MEDICATIONS (VERAPAMIL, NITROGLYCERIN, AND HEPARIN). AFTER PLACING THE SHEATH, THE BMX81 WAS ADVANCED INTO THE VESSEL. WHILE ADVANCING THE BMX81 INTO THE VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO REMOVE THE BMX81. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE BMX81 HAD FRACTURED ON THE DISTAL END NEAR THE MARKERBAND. IT WAS NOTED THAT THE TIP OF THE BMX81 HAD MOVED INTO AN ADJACENT ARTERY. AFTER ASSESSING WITH A SECOND PHYSICIAN, IT WAS DECIDED TO LEAVE THE FRACTURED TIP IN THE PATIENT''S VESSEL. THE PROCEDURE WAS COMPLETED WITH A NEW BMX81 WITH RIGHT FEMORAL ACCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20377689 ↗