ACE 5MAXACE064Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548013961), received between Sep 3, 2015 and Nov 11, 2019 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Kinked” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2019Break; Fracture; Physical Resistance/Sticking; Break; 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 ACE 64 REPERFUSION CATHETER (ACE64) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE INTERNAL CAROTID ARTERY (ICA) FOLLOWED BY THE ACE64. UPON ADVANCEMENT OF THE ACE64, THE PHYSICIAN MET UNUSUAL RESISTANCE. AN ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN VISUALIZED THAT THE DIAMETER OF THE ACE64 WAS TOO SMALL AND THAT THE NEURON MAX MAY HAVE KINKED MID-SHAFT. THE PHYSICIAN DECIDED TO REMOVE THE ACE64 AND REPLACE IT WITH A LARGER CATHETER; HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE ACE64 WAS RETRACTED A FEW CENTIMETERS BACK INTO THE NEURON MAX. SUBSEQUENTLY, THE ACE64 BECAME STUCK AND BROKE IN THE NEURON MAX. THE DISTAL PART OF THE ACE64 REMAINED IN THE NEURON MAX, THEREFORE, THE NEURON MAX AND BROKEN ACE64 WERE REMOVED TOGETHER FROM THE PATIENT. IT WAS REPORTED THAT, UPON REMOVAL OF THE NEURON MAX, NO KINK WAS FOUND. HOWEVER, THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). THERE WAS NO REPORT OF AN ADVERSE EFFE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9303017 ↗
• MalfunctionMay 7, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) WAS BROKEN WHEN TAKEN OUT OF THE HOOP RETAINER. THE DAMAGE TO THE ACE64 WAS FOUND PRIOR TO USE. THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7491709 ↗
• MalfunctionDec 7, 2017Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, AFTER ADVANCING THE PSR3D THROUGH THE ACE64 AND CAPTURING THE CLOT, THE PHYSICIAN ATTEMPTED TO RETRACT THE PSR3D INTO THE ACE64. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE ATTEMPTING TO RETRACT THE ACE64 AND PSR3D FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE ACE64 WAS STRETCHING. THEREFORE, THE PHYSICIAN LOOSENED THE ROTATING HEMOSTASIS VALVE (RHV) AND REMOVED THE ACE64 CONTAINING THE PSR3D FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE STENT COMPONENT OF THE PSR3D WAS SEPARATED FROM THE PUSHER WIRE AND STUCK INSIDE THE ACE64, BUT THE CLOT WAS STILL ATTACHED TO THE PSR3D. THE FINAL ANGIOGRAPHY REVEALED THAT THE THROMBECTOMY PROCEDURE WAS SUCCESSFULLY PERFORMED AND THE PROCEDURE WAS COMPLETED AT THIS POINT. IN ADDITION, THERE WAS NO ALLEGED DEFICIENCY WITH THE NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7098041 ↗
• MalfunctionFeb 16, 2017Structural Problem; Device Operates Differently Than Expected; Structural Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE RADIOPAQUE MARKER ON THE DISTAL TIP OF THE ACE 64 WAS NOT FULLY VISIBLE AND WAS PARTIALLY SEEN UNDER FLUOROSCOPY. THEREFORE, THE ACE 64 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6337595 ↗
• MalfunctionDec 21, 2016Kinked; Aspiration Issue; Material Deformation; Kinked; Aspiration Issue; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, AFTER SUCCESSFULLY USING THE ACE 64 TO ASPIRATE THROMBUS, THE PHYSICIAN NOTICED THE ASPIRATION WAS NO LONGER EFFECTIVE; THEREFORE THE ACE 64 WAS REMOVED. UPON REMOVING THE ACE 64 FROM THE PATIENT, THE PHYSICIAN NOTICED IT HAD BECOME KINKED, OVALIZED AND WAS COLLAPSING. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW ACE 64 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6196212 ↗
• MalfunctionJul 7, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, WHILE REMOVING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) FROM ITS PACKAGING, THE HOSPITAL STAFF INADVERTENTLY KINKED THE PROXIMAL END (3-4 CENTIMETERS FROM THE HUB) OF THE DEVICE. THE ACE 64 BECAME KINKED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5774388 ↗
• MalfunctionJun 23, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE BEING USED THROUGH THE ACE 64 TO REMOVE THROMBUS, THE 3MAX WAS PULLED BACK AND IT BECAME STUCK INSIDE THE ACE 64, AND THE 3MAX TIP SEPARATED INSIDE THE ACE 64; THEREFORE, THE PHYSICIAN REMOVED THE ACE 64 WITH THE 3MAX INSIDE AND COMPLETED THE PROCEDURE USING A NEW 3MAX WITH A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5746472 ↗
• InjuryJun 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE USING THE ACE TO REMOVE THROMBUS, THE PATIENT SUFFERED A MILD VASOSPASM IN THE INTERNAL CAROTID ARTERY AND THE M1 SEGMENT OF THE MCA. THE VASOSPASM WAS REPORTED AS FULLY RESOLVED AND NO ACTIONS WERE TAKEN TO RESOLVE IT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THIS VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE ACE 64.

  Patient problems: Vasoconstriction

  MAUDE report 5697803 ↗
• MalfunctionMay 17, 2016Kinked; No Pressure; Kinked; No Pressure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE ACE 64 WAS KINKED AROUND THE HUB AREA WHICH THEN CAUSED FALSE AIR DURING ASPIRATION. THE PHYSICIAN REPORTED FEELING NO PARTICULAR RESISTANCE PRIOR TO THIS DAMAGE. THE KINKED ACE 64 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5660290 ↗
• MalfunctionMay 17, 2016Kinked; No Pressure; Kinked; No Pressure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE ACE 64 WAS KINKED AROUND THE HUB AREA WHICH THEN CAUSED FALSE AIR DURING ASPIRATION. THE PHYSICIAN REPORTED FEELING NO PARTICULAR RESISTANCE PRIOR TO THIS DAMAGE. THE KINKED ACE 64 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5660289 ↗
• MalfunctionMay 5, 2016Fracture; Stretched; Fracture; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE RETRACTING THE ACE 64 FROM THE PATIENT'S TORTUROUS ANATOMY, THE ACE 64 BECAME STRETCHED AND FRACTURED. THE DISTAL PART OF THE ACE WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5635594 ↗
• MalfunctionMay 3, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE USING THE 3MAX AND ACE 64, THE PHYSICIAN EXPERIENCED NO UNUSUAL RESISTANCE; HOWEVER, THE 3MAX AND ACE 64 BECAME KINKED AND WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAX AND A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5624835 ↗
• MalfunctionApr 8, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM THE DISPENSER HOOP. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5563959 ↗
• MalfunctionFeb 9, 2016Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE SHAFT OF THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS DAMAGED UPON REMOVAL FROM ITS PACKAGING. THE DAMAGED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5420260 ↗
• MalfunctionFeb 2, 2016Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, WHILE THE NEURON MAX WAS BEING ADVANCED IN THE PATIENT, IT BECAME KINKED. THE PHYSICIAN DID NOT REPORT ANY RESISTANCE AND DID NOT APPLY ANY FORCE; HOWEVER, IT WAS INDICATED THAT THERE WAS TORTUOUS ARCH ACCESS. DUE TO THE NEURON MAX BEING KINKED, THE ACE 64 AND THE 3MAX CATHETER WERE BOTH STRETCHED WHILE BEING RETRACTED THROUGH THE KINKED AREA OF THE NEURON MAX. ALL THREE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, A NEW ACE 64 AND A NEW 3MAX CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5404033 ↗
• InjuryDec 23, 2015Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE ACE 64 FRACTURED WHILE BEING USED INSIDE THE PATIENT. THE PHYSICIAN REQUIRED A SNARE DEVICE TO REMOVE THE FRACTURED ACE 64. THE PROCEDURE SUCCESSFULLY CONTINUED USING A STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5323956 ↗
• MalfunctionDec 1, 2015Difficult To Position

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, THE PHYSICIAN USED THE 3MAX TO NAVIGATE THE ACE64 TO THE M1 SECTION OF THE MCA, THEN REMOVED THE 3MAX AND STARTED ASPIRATING THE CLOT THROUGH THE ACE64; HOWEVER, RECANALIZATION WAS MILD AND THE THROMBUS APPEARED TO INVOLVE THE DISTAL M2 BRANCH AS WELL. THE PHYSICIAN DECIDED TO USE THE 3MAX AGAIN IN ORDER TO NAVIGATE THE ACE64 TO THE M2 BRANCH, BUT THE M2 WAS TOO TIGHT FOR THE ACE64 TO PASS THROUGH IT SO THE PHYSICIAN USED THE 3MAX FOR ASPIRATION; HOWEVER, NO CLOT OR BLOOD FLOW WAS VISIBLE IN THE ASPIRATION TUBING SO THEY DECIDED TO REMOVE THE 3MAX. THE PHYSICIAN PULLED THE 3MAX BACK GENTLY AND THEN WITH FORCE, BUT THE 3MAX DID NOT MOVE UNTIL IT BECAME ELONGATED AND THEY WERE ABLE TO RETRACT IT. THE 3MAX WAS REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S DEVICE; HOWEVER, IT WAS ALSO UNSUCCESSFUL IN ESTABLISHING RECANALIZATION. THE PROCEDURE STOPPED SINCE RECANALIZATION COULD NOT BE ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5259775 ↗
• MalfunctionOct 26, 2015Fracture; Kinked; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING PREPARATION FOR THE PROCEDURE, A KINK WAS NOTICED ON THE HUB PORTION OF THE ACE 64; HOWEVER, THE PHYSICIAN CONTINUED USING THE ACE 64 FOR THE PROCEDURE. DURING THE PROCEDURE, UPON INITIATING ASPIRATION, THE PHYSICIAN DISCOVERED "FALSE AIR" IN THE SYSTEM AND DECIDED TO REMOVE THE ACE 64 FROM THE PATIENT. HOWEVER, DURING REMOVAL OF THE ACE 64, THE HUB PORTION OF THE ACE 64 COMPLETELY FRACTURED. THE PROCEDURE CONTINUED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5179135 ↗
• MalfunctionSep 3, 2015Fracture; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). UPON REMOVAL FROM THE PACKAGING, THE ACE 64 WAS FOUND BROKEN AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW ACE 64.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 5054664 ↗