Penumbra System 3MAXCKITRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548016757), received between Jan 11, 2017 and Feb 27, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA ENGINE (ENGINE), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS AND HAD ARTERIOSCLEROSIS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A DIRECT ASPIRATION FIRST PASS (ADAPT) USING THE 3MAXC AND PARTIAL RECANALIZATION OF THE TARGET VESSEL WAS ACHIEVED. WHEN THE 3MAXC PASSED THROUGH THE LESION A SECOND TIME, RESISTANCE WAS ENCOUNTERED. IT WAS ALSO REPORTED THAT THERE WAS NO REVERSE FLOW AFTER ASPIRATING THE THROMBUS. WHILE RETRACTING THE 3MAXC AND CATHETER INTO THE SHEATH UNDER NEGATIVE PRESSURE, RESISTANCE WAS ENCOUNTERED. UPON REMOVAL, THE 3MAXC WAS FOUND FRACTURED AND THE DISTAL END OF THE 3MAXC REMAINED IN THE M1 TO THE INTERNAL CAROTID ARTERY (ICA). NEXT, A SNARE DEVICE WAS USED TO RETRIEVE THE FRACTURED PIECE OF THE 3MAXC. ON THE BACK TABLE, THE PHYSICIAN NOTED THAT THE DISTAL END OF THE 3MAXC WAS KINKED NEAR THE FRACTURE AND WAS LIKELY CAUSED BY THE SNARE DEVICE. AT THIS POINT, THE PROCEDURE WAS ENDED. IT WAS ALSO NOTED THAT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444262 ↗
• MalfunctionJan 17, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND A GUIDEWIRE. DURING THE PROCEDURE, THE 3MAXC WAS ADVANCED TO THE TARGET LOCATION AND USED TO PERFORM ASPIRATION. WHILE WITHDRAWING THE 3MAXC FROM THE ACE68, RESISTANCE WAS ENCOUNTERED AND THE 3MAXC BECAME STUCK WHEN THE DISTAL END OF THE 3MAXC WAS APPROXIMATELY ONE MILLIMETER OUTSIDE OF THE ACE68. THE PHYSICIAN CONTINUED TO RETRACT THE 3MAXC OVER THE GUIDEWIRE AND SUBSEQUENTLY, THE 3MAXC BROKE IN TWO PIECES AT THE PROXIMAL END. THEREFORE, THE ACE68 CONTAINING THE BROKEN 3MAXC WAS REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THE 3MAXC WAS CRUSHED AND KINKED NEAR THE LOCATION OF THE BREAK AT THE PROXIMAL END. AT THIS POINT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO ADDITIONAL PASSES WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16188067 ↗
• MalfunctionMay 3, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE 3MAXC INTO THE GUIDE CATHETER AND THEN INSERTED THE GUIDEWIRE INTO THE 3MAXC; HOWEVER, THE GUIDEWIRE BECAME STUCK IN THE MIDDLE SHAFT OF THE 3MAXC AND GUIDE CATHETER. THE 3MAXC WAS THEREFORE, REMOVED OUT FROM THE GUIDE CATHETER. SUBSEQUENTLY, THE PHYSICIAN FLUSHED THE 3MAXC ON THE BACK TABLE AND THEN INSERTED THE SAME GUIDEWIRE INTO THE 3MAXC, BUT AGAIN, IT BECAME STUCK INSIDE THE 3MAXC. THEREFORE, THE 3MAXC WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC WITH THE SAME GUIDE CATHETER AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760476 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), NON-PENUMBRA GUIDE CATHETER, GUIDE, AND GUIDEWIRE. IT WAS REPORTED THAT THE 3MAXC AND GUIDE CATHETER WERE FLUSHED WITH SALINE PRIOR TO USE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING THE 3MAXC THROUGH THE MIDDLE OF THE GUIDE CATHETER. THE 3MAXC WAS REMOVED AND UPON FLUSHING ON THE BACK TABLE USING A SYRINGE, THE DISTAL TIP OF THE 3MAXC WAS OVALIZED. THEREFORE, THE 3MAXC WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704127 ↗
• MalfunctionMar 8, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN INJECTED TISSUE PLASMINOGEN ACTIVATOR (TPA) AND SUBSEQUENTLY PLACED THE GUIDE CATHETER IN THE INTERNAL CAROTID ARTERY (ICA) AND THE ACE68 WAS ADVANCED INTO THE CAROTID SIPHON. NEXT, THE 3MAXC WAS PASSED THROUGH THE CLOT TOWARDS THE TARGET LOCATION. THE PHYSICIAN REMOVED THE 3MAXC AND GUIDEWIRE FROM THE ACE68 IN ORDER TO BEGIN ASPIRATION AND NOTICED THAT THE 3MAXC WAS STRETCHED. THEREFORE, THE 3MAXC WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO OTHER STENT RETRIEVERS, THE SAME GUIDE CATHETER, AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441264 ↗
• MalfunctionDec 8, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), PENUMBRA ENGINE (ENGINE), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE DISTAL TIP OF THE 3MAXC INTO THE TARGET VESSEL AND STARTED ASPIRATION WITH THE ENGINE USING ADAPT TECHNIQUE. SUBSEQUENTLY, 90 SECONDS AFTER THE BLOOD INFLOW STOPPED, THE PHYSICIAN ATTEMPTED TO REMOVE THE 3MAXC. IT APPEARED THAT THE MARKER BAND OF THE 3MAXC BROKE WHILE RETRACTING THE 3MAXC. THEREFORE, THE PHYSICIAN TURNED OFF THE ENGINE AND REMOVED THE 3MAXC. UPON REMOVAL, THE 3MAXC WAS OBSERVED TO BE BROKEN. IT WAS REPORTED THAT THERE WAS A BREAK 55MM FROM THE DISTAL TIP OF THE 3MAXC ON THE BACK TABLE. HOWEVER, THE PHYSICIAN CONFIRMED THAT THE MARKER BAND TIP WAS NOT INSIDE THE PATIENT. THE PHYSICIAN CONTINUED THE PROCEDURE USING AN ACE68 WITH THE SAME CATHETER, ENGINE, AND CANISTER BUT WAS UNABLE TO ACHIEVE RECANALIZATION. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10968794 ↗
• MalfunctionSep 4, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA GUIDE, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INTRODUCING THE DEVICES TO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE GUIDEWIRE BECAME STUCK AFTER BEING ADVANCED APPROXIMATELY NINETY CENTIMETERS THROUGH THE 3MAXC. IT WAS REPORTED THAT THE SAME ISSUE HAD PREVIOUSLY OCCURRED ON THE BACK TABLE, PRIOR TO INTRODUCTION TO THE PATIENT. THEREFORE, THE 3MAXC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, THE SAME ACE60, AND A STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497098 ↗
• MalfunctionJul 24, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, WHILE FLUSHING THE 3MAXC ON THE BACK TABLE, THE 3MAXC WAS OBSERVED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323836 ↗
• MalfunctionFeb 21, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR MEDICAL PROCEDURE, THE HOSPITAL TECHNICIAN FOUND THAT THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WAS KINKED IN TWO PLACES UPON REMOVAL FROM THE PACKAGING OF THE PENUMBRA SYSTEM 3MAX HI-FLOW KIT. THE DAMAGE TO THE 3MAXC WAS FOUND PRIOR TO USE AND THEREFORE THE 3MAXC WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 7286225 ↗
• MalfunctionJan 11, 2017Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) WAS FRACTURED ALONG ITS SIDE UPON REMOVAL FROM ITS PACKAGING. THE FRACTURED 3MAX WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6244398 ↗