Benchmark MAX System BMX96100SIM125-ARecalls & reported problems
Penumbra, Inc. · BMX96 100cm, 6F SIM 125cm Select · Class 2
All models of Benchmark MAX System (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948022713), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON CAROTID ARTERY USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), NEURON SELECT CATHETER 6F (6F SELECT), A GUIDEWIRE AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE DILATOR INTO THE BMX96. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE 6F SELECT INTO THE BMX96 BUT WOULD STILL EXPERIENCE RESISTANCE. SUBSEQUENTLY, UPON INSPECTING THE BMX96, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THE DISTAL END OF THE BMX96 WAS FRACTURED. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE WITH ANOTHER SELECT CATHETER THROUGH THE FRACTURED BMX96 AND REMOVED THE ENTIRE BMX96. THE PROCEDURE WAS COMPLETED USING A NEW BMX96 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 18937996 ↗
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page