Benchmark MAX System BMX7F95-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948024663), received between Jan 23, 2025 and Nov 21, 2025 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Fracture; Fracture

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 81 ACCESS SYSTEM (BMX81). AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN WAS REMOVING THE BMX81 FROM THE PATIENT AND NOTICED THE BMX81 HAD FRACTURED. THEREFORE, THE PHYSICIAN PLACED A GUIDEWIRE THROUGH THE FRACTURED BMX81 AND ADVANCED A NEURON SELECT CATHETER 5F (5F SELECT) OVER THE GUIDEWIRE AND THROUGH THE FRACTURED BMX81. THE FRACTURED BMX81 WAS THEN REMOVED TOGETHER WITH THE 5F SELECT AND GUIDEWIRE AS A UNIT. IT WAS REPORTED THAT THE ENTIRE FRACTURED BMX81 WAS REMOVED, AND NO PART OF THE BMX81 WAS LEFT IN THE PATIENT. THE PROCEDURE HAD 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 23623426 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX 81 ACCESS SYSTEM (BMX81) AND A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS IN THE TARGET LOCATION USING THE RED62. AFTER THE PASS, THE RED62 WAS REMOVED TO BE FLUSHED, AND THE PHYSICIAN NOTICED THE BMX81 DISTAL END BECAME OCCLUSIVE TO THE VESSEL AND DISSECTED THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN PLACED A STENT IN THE CAROTID. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43).

  Patient problems: Vascular Dissection

  MAUDE report 22946461 ↗
• InjuryJan 23, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TRANSVERSE SIGMOID SINUS USING A BENCHMARK BMX81 ACCESS SYSTEM (BMX81), A STENT, AND A GUIDEWIRE. DURING THE PROCEDURE, THE BMX81 WAS ADVANCED INTO THE VESSEL. NEXT, WHILE ADVANCING A STENT THROUGH THE BMX81 INTO THE VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE STENT BECAME STUCK PARTIALLY OUTSIDE OF THE BMX81. WHILE ATTEMPTING TO PUSH THE STENT OUT WITH THE GUIDEWIRE, THE PHYSICIAN FRACTURED THE BMX81 AT THE DISTAL END. THEREFORE, THE PROXIMAL PORTION OF THE BMX81 WAS REMOVED. A SNARE WAS ADVANCED TO THE VESSEL TO REMOVE THE FRACTURED PORTION OF THE BMX81; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THE DISTAL PORTION OF THE BMX81 WAS LEFT IN THE RIGHT CAROTID ARTERY. THE PROCEDURE HAD ENDED AT THIS POINT. LATER, THE PATIENT EXPIRED DUE TO OTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21218354 ↗