Benchmark MAX System BMX7F95M-ARecalls & reported problems
Penumbra, Inc. · BMX81 95cm, MP Tip · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948024670), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX 81 ACCESS SYSTEM (BMX81), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SHEATH THROUGH THE PATIENT¿S TORTUOUS ANATOMY. THEREFORE, THE SHEATH WAS REMOVED. THE PHYSICIAN THEN WAS ABLE TO ADVANCE A SECOND SHEATH TO THE TARGET LOCATION AND THE BMX81 WAS ADVANCED THROUGH THE SHEATH. UPON COMPLETION OF THE PROCEDURE, WHILE RETRACTING THE BMX81 FROM THE PATIENT, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CERVICAL PORTION OF THE INTERNAL CAROTID ARTERY (ICA) WAS DISSECTED. THERE WAS NO REPORTED DAMAGE TO THE BMX81. THE PHYSICIAN THEN PLACED A STENT OVER THE DISSECTION. THE PROCEDURE ENDED AT THIS POINT.
Patient problems: Vascular Dissection
MAUDE report 17206436 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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