Benchmark MAX System BMX9690BER125-BRecalls & reported problems
Penumbra, Inc. · BMX96 90cm, STR Tip, 6F BER 125cm Select · Class 2
All models of Benchmark MAX System (13)
Data updated Oct 18, 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 00815948026322), received between Oct 31, 2024 and Oct 31, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Physical Resistance/Sticking1
- Stretched1
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.
MalfunctionOct 31, 2024Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A NON-PENUMBRA SHEATH (8F). DURING THE PROCEDURE, THE RIGHT FEMORAL ARTERY WAS ACCESSED WITH THE SHEATH. THE PHYSICIAN ADVANCED A BMX96 AND RED72 TO THE TARGET LOCATION. IT WAS REPORTED THAT THE RED72 WAS UNABLE TO BE ADVANCED PAST THE CAVERNOUS SEGMENT OF THE ICA. THE PHYSICIAN THEN ADVANCED A RED43 THROUGH THE RED72 TO THE TARGET LOCATION. AFTER INITIATING ASPIRATION, THE DISTAL PORTION OF THE RED43 WAS NOTICED TO BE FRACTURED UNDER FLUOROSCOPY. THE FRACTURED SEGMENT OF THE RED43 WAS NOTICED TO BE AGAINST THE THROMBUS IN THE M1. THE PHYSICIAN REMOVED THE PROXIMAL SEGMENT OF THE RED43. NEXT, WHILE REMOVING THE RED72 FROM THE BMX96, THE PHYSICIAN NOTED RESISTANCE. THE PHYSICIAN THEN DECIDED TO REMOVE THE RED72 AND BMX96 TOGETHER FROM THE PATIENT, HOWEVER, RESISTANCE WAS ENCOUNTERED AND, SUBSEQUENTLY, THE RED72 AND BMX96 STRETCHED AND FRACTURED AT THE DISTAL LOCATION WITHIN THE SHEAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20582859 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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