BenchmarkRecalls & reported problems across all models
Penumbra, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 307
- Deaths reported
- 1
- Injuries reported
- 28
- Recalls
- 0
We found 17 models of Benchmark by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 307 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2015 and Apr 16, 2026 — classified as 1 death, 28 injuries, 278 malfunctions.
The most frequently reported specific device problem is “Break” (98 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Benchmark problems
Device problems
- Break98
- Device Damaged Prior to Use91
- Fracture67
- Material Deformation51
- Out-Of-Box Failure50
- Kinked41
- Physical Resistance/Sticking40
- Leak/Splash26
Patient problems
- No Patient Involvement105
- No Clinical Signs, Symptoms or Conditions101
- No Consequences Or Impact To Patient87
- Vasoconstriction7
- Foreign Body In Patient6
- No Known Impact Or Consequence To Patient5
- Hematoma3
- Insufficient Information3
Benchmark models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Benchmark BMK6F95BER120CATHETER, PERCUTANEOUS84 reports
- Benchmark BMK6F95MBER120CATHETER, PERCUTANEOUS55 reports
- Benchmark BMK6F105MCATHETER, PERCUTANEOUS38 reports
- Benchmark BMK6F105BER130CATHETER, PERCUTANEOUS30 reports
- Benchmark BMK6F105MBER130CATHETER, PERCUTANEOUS26 reports
- Benchmark BMK6F95MCATHETER, PERCUTANEOUS19 reports
- Benchmark BMK6F95CATHETER, PERCUTANEOUS12 reports
- Benchmark BMK6F95BER120-ACATHETER, PERCUTANEOUS11 reports
- Benchmark BMK6F105CATHETER, PERCUTANEOUS8 reports
- Benchmark BMK6F115MCATHETER, PERCUTANEOUS7 reports
- Benchmark BMK6F105BER130-ACATHETER, PERCUTANEOUS1 death6 reports
- Benchmark BMK6F95MBER120-ACATHETER, PERCUTANEOUS4 reports
- Benchmark BMK6F115CATHETER, PERCUTANEOUS2 reports
- Benchmark BMK6F105MBER130-ACATHETER, PERCUTANEOUS2 reports
- Benchmark BMK6F105-ACATHETER, PERCUTANEOUS1 report
- Benchmark BMK6F105M-ACATHETER, PERCUTANEOUS1 report
- Benchmark BMK6F115-ACATHETER, PERCUTANEOUS1 report
Recent Benchmark adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BILATERAL SPHENOPALATINE ARTERY (SPA) THROUGH BILATERAL EXTERNAL CAROTID ARTERY (ECA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA LONG SHEATH (6FR), A COPILOT HEMOSTATIC VALVE, AND A GUIDEWIRE. THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE BENCHMARK FRACTURED WITHIN THE SHEATH. IT WAS REPORTED ALL ACCESS WAS REMOVED INCLUDING THE BENCHMARK FROM THE PATIENT REQUIRING RE-PUNCTURE TO RESTART THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896727 ↗MalfunctionApr 11, 2026Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE DEVICE WAS REPORTED TO HAVE FRACTURED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852177 ↗InjuryMar 30, 2026Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). THE PHYSICIAN INSERTED THE BENCHMARK VIA TRANSRADIAL ACCESS AND OBSERVED VASOSPASMS. WHILE ATTEMPTING TO REMOVE THE BENCHMARK, THE PHYSICIAN EXPERIENCED DIFFICULTY AND FOUND THAT THE BENCHMARK FRACTURED IN THE BRACHIAL ARTERY. THE FRACTURED BENCHMARK WAS REMOVED VIA TRANSFEMORAL ACCESS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX).NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED.
Patient problems: Vasoconstriction
MAUDE report 24719417 ↗MalfunctionMar 13, 2026Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH (6F), NON-PENUMBRA COILS, AND LIQUID EMBOLIC AGENTS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR OR FIVE COILS IN THE TARGET LOCATION. UPON REMOVAL OF THE MICROCATHETER AND BENCHMARK, THE PHYSICIAN FOUND THAT THE BENCHMARK HAD FRACTURED MID-SHAFT. IT WAS NOTED THAT THE FRACTURED SEGMENT OF THE BENCHMARK WAS WITHIN THE AORTA. THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FRACTURED SEGMENT OF THE BENCHMARK FROM THE PATIENT. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592241 ↗MalfunctionFeb 12, 2026Fracture
THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER (5F SELECT), AND A SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO THE AORTA, THE BENCHMARK FRACTURED AT THE MID-SHAFT. THE FRACTURE OCCURRED WITHIN THE SHEATH. SUBSEQUENTLY, THE SHEATH AND FRACTURED BENCHMARK WAS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327222 ↗InjuryFeb 6, 2026Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE SUBCLAVIAN ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PHYSICIAN USED RADIAL ACCESS FOR THE PROCEDURE. AFTER COMPLETION OF THE PROCEDURE, WHILE REMOVING THE BENCHMARK, THE BENCHMARK FRACTURED. THE PROXIMAL PORTION OF THE BENCHMARK WAS REMOVED FROM THE RADIAL ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE REMAINING PORTION OF THE BENCHMARK USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. ON (B)(6) 2026, THE REMAINING PORTION OF THE BENCHMARK WAS REMOVED VIA SURGICAL CUT DOWN USING FEMORAL ACCESS.
Patient problems: Foreign Body In Patient
MAUDE report 24284817 ↗InjuryJan 23, 2026Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA SHEATH (6F). DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK INTO A SMALLER BRANCH OF THE RIGHT RADIAL ARTERY VIA RIGHT RADIAL ACCESS, THE BENCHMARK BECAME STUCK. WHILE RETRACTING THE BENCHMARK, THE BENCHMARK FRACTURED IN HALF. NO ATTEMPTS WERE MADE TO REMOVE THE FRACTURED SEGMENT OF THE BENCHMARK. THE PHYSICIAN THEN GAINED FEMORAL ACCESS AND TREATED BOTH SIDES OF THE MMA. THE FRACTURED SEGMENT OF THE BENCHMARK WAS LEFT IN THE PATIENT¿S ARM. THE PHYSICIAN CURRENTLY HAS NO PLANS FOR REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 24166060 ↗MalfunctionDec 18, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VENOUS SINUS USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA STENT. WHILE RETRACTING THE BENCHMARK TO PLACE THE STENT IN THE TARGET LOCATION, THE BENCHMARK FRACTURED AT THE DISTAL END. IT WAS REPORTED THAT THE STENT WAS ALSO FRACTURED. THE PROXIMAL END OF THE BENCHMARK WAS REMOVED. A STENT RETRIEVER WAS USED TO SUCCESSFULLY REMOVE THE REMAINING DISTAL SEGMENT OF THE BENCHMARK AND THE FRACTURED PORTION OF THE STENT. IT WAS REPORTED THAT THE REMAINING PORTION OF THE STENT WAS LEFT IN THE VENOUS SINUS. THE PROCEDURE WAS ABORTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839940 ↗InjuryNov 13, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHEATH (6F), A NON-PENUMBRA BALLOON CATHETER (0.014" 4MM X 40MM 142CM), AND A GUIDEWIRE (0.035 250CM). IT WAS REPORTED THAT THERE WAS STENOSIS IN THE ICA. THE PHYSICIAN GAINED TRANS-RADIAL ACCESS USING THE SHEATH. IT WAS NOTED THAT A RADIAL COCKTAIL OF VERAPAMIL AND HEPARIN WAS ADMINISTERED PRIOR TO THE PROCEDURE. THE PHYSICIAN ADVANCED THE BENCHMARK AND THE BALLOON CATHETER THROUGH THE SHEATH TO THE TARGET LOCATION AND PERFORMED BALLOON ANGIOPLASTY. THE BALLOON CATHETER WAS REMOVED. WHILE RETRACTING THE BENCHMARK, RESISTANCE WAS ENCOUNTERED, RESULTING IN A FRACTURE WITHIN THE BRACHIAL ARTERY. A VASOSPASM WAS OBSERVED IN THE SAME VESSEL. NITROGLYCERIN WAS ADMINISTERED TO TREAT THE VASOSPASM; HOWEVER, THE EVENT WAS NOT RESOLVED. THE PHYSICIAN ATTEMPTED TO RETRACT THE BENCHMARK, BUT THE BENCHMARK COULD NOT BE REMOVED. THE PHYSICIAN DECIDED TO CUT THE BENCHMARK AT THE RADIAL ACCESS SITE. THE PATIENT WAS TRANSFERRED FOR SURGICAL CUT DOWN. THE BENCHMARK WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED T
Patient problems: Foreign Body In Patient; Vasoconstriction
MAUDE report 23543903 ↗MalfunctionSep 5, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA LONG SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE BENCHMARK THROUGH THE LONG SHEATH, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE MARKERBAND OF THE BENCHMARK FRACTURED WITHIN THE LONG SHEATH AND MIGRATED INTO THE MIDDLE CEREBRAL ARTERY (MCA). THEREFORE, THE BENCHMARK WAS REMOVED. THE PHYSICIAN DECIDED NOT TO REMOVE THE MARKER BAND FROM THE MCA SINCE IT WAS NOT OBSTRUCTING THE FLOW. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME LONG SHEATH.
Patient problems: Foreign Body In Patient
MAUDE report 22984093 ↗MalfunctionMay 2, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO RETRACT THE 5F SELECT AND DECIDED TO REMOVE IT WITH THE BENCHMARK. UPON REMOVAL OF THE 5F SELECT AND BENCHMARK, IT WAS NOTED THAT THE BENCHMARK HAD FRACTURED. THE PHYSICIAN THEN USED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FRACTURED SEGMENT OF THE BENCHMARK FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NEURON SELECT CATHETER 6F (6F SELECT). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953806 ↗MalfunctionMar 19, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A SHEATH, COILS, A FLOW DIVERTER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE BENCHMARK IN THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). UPON REMOVAL AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE BENCHMARK WAS FRACTURED AND THE PROXIMAL THIRD WAS RETRIEVED. THE PHYSICIAN THEN GAINED ACCESS IN THE OPPOSITE FEMORAL ARTERY AND USED A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT OF THE BENCHMARK. THE PROCEDURE ENDED AT THIS POINT. DUE TO THE PATIENT'S DUAL ANTIPLATELET THERAPY (DAPT), THE PHYSICIAN WAS UNABLE TO USE AN ANGIOSEAL AND INSTEAD APPLIED PROLONGED MANUAL PRESSURE TO THE GROIN. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646803 ↗DeathFeb 26, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE BASILAR ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN WAS WITHDRAWING THE BENCHMARK AND FELT RESISTANCE. THE PHYSICIAN CONTINUED TO PULL THE BENCHMARK CAUSING IT TO STRETCH AND FRACTURE APPROXIMATELY 30CM FROM THE HUB. AN OPEN SURGERY WAS PERFORMED TO REMOVE THE REMAINING PORTION OF THE BENCHMARK FROM THE ILIAC/AORTA/VERTEBRAL ARTERY. AFTER THE SURGERY, THE PATIENT WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU). IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2025 DUE TO COMPLICATIONS OF THE PROCEDURE AND A BRAIN HEMORRHAGE. THE PHYSICIAN ATTRIBUTED THE PROCEDURAL COMPLICATIONS RESULTING IN PATIENT EXPIRATION TO THE FRACTURED BENCHMARK.
Patient problems: Insufficient Information
MAUDE report 21473365 ↗InjuryFeb 21, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS, AND A SHEATH (6FR) VIA THE RADIAL ARTERY. DURING THE PROCEDURE, THE PHYSICIAN NOTED A VASOSPASM IN THE RADIAL ARTERY, SO HE ADMINISTERED VERAPAMIL, BUT THE VASOSPASM CONTINUED. NEXT, THE PHYSICIAN ATTEMPTED TO REMOVE THE BENCHMARK, HOWEVER DUE TO THE VASOSPASM; THE BENCHMARK STRETCHED AND FRACTURED IN THE ARTERY AROUND THE ELBOW. VASCULAR SURGERY WAS CONSULTED AND REMOVED THE FRACTURED DISTAL TIP VIA SURGICAL CUTDOWN. THE PROCEDURE WAS COMPLETED WITH A NEW BENCHMARK, NEW MICROCATHETER, AND A NEW SHEATH VIA THE FEMORAL ARTERY.
Patient problems: Vasoconstriction
MAUDE report 21438723 ↗MalfunctionFeb 7, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN NOTICED THAT THE BENCHMARK FRACTURED. THEREFORE, THE 5F SELECT AND PROXIMAL PORTION OF THE BENCHMARK WERE REMOVED. AFTER A FEW ATTEMPTS, THE PHYSICIAN SUCCESSFULLY REMOVED THE DISTAL PART OF THE BENCHMARK USING A SNARE DEVICE. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21339825 ↗
Other Penumbra, Inc. products
- RUBY Coil90 models · 2,838 reports
- Smart Coil98 models · 2,616 reports
- Penumbra System59 models · 2,164 reports · 4 recalls
- POD24 models · 1,947 reports
- Indigo System64 models · 1,873 reports
- Penumbra Coil 400120 models · 842 reports
- Lantern Delivery Catheter11 models · 817 reports
- LP Coil System38 models · 725 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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