ACE 5MAXACE068KIT-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00815948022850), received between Feb 19, 2021 and Mar 7, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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.

• MalfunctionMar 7, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 THROUGH THE NEURON MAX INTO THE DISTAL ICA AND COMPLETED ONE PASS. WHILE ATTEMPTING TO REMOVE THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE ACE68 FRACTURED, LEAVING A FRACTURED SEGMENT IN THE PROXIMAL ICA. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE FRACTURED SEGMENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER ASPIRATION CATHETER, THE SAME NEURON MAX, AND A STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554279 ↗
• MalfunctionJul 12, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A PENUMBRA ENGINE (ENGINE), A NON-PENUMBRA SHEATH, A NON-PENUMBRA INTERMEDIATE CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 OVER THE GUIDEWIRE TO THE OCCLUSION SITE AND INITIATED ASPIRATION USING THE ENGINE AND A SYRINGE ATTACHED TO THE SHEATH. AFTER SUCCESSFULLY COMPLETING ONE PASS, THE PHYSICIAN ATTEMPTED TO RETRACT THE ACE68 BUT NOTICED A CURVE IN THE DISTAL END OF THE SHEATH. THE PHYSICIAN THEN PROCEEDED TO RETRACT THE ACE68; HOWEVER, IT WAS OBSERVED THAT THE RADIO MARKER OF THE ACE68 WAS NOT RESPONDING TO THE RETRACTION AND REMAINED IN PLACE. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL LENGTH OF THE ACE68 HAD UNRAVELED AND FRACTURED APPROXIMATELY 10 TO 15 CENTIMETERS FROM THE DISTAL END. IT WAS REPORTED THAT THE DISTAL FRAGMENT OF THE ACE68 WAS IN THE CAROTID ARTERY IN FRONT OF THE DISTAL END OF THE INTERMEDIATE CATHETER. THE PHYSICIAN THEN CONNECTED THE ENGINE, ACTIVATED THE ASPIRATION DIRECTLY TO THE INTERMEDIATE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736291 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA MICROCATHETER, STENT RETRIEVERS, AND GUIDEWIRES. IT WAS NOTED THAT THE PATIENT HAD A SEVERE CARDIAC ILLNESS AND PRESENTED WITH SEVERE LEFT HEMIPARESIS AND DYSARTHRIA. AT THE TIME OF DISCHARGE, THE PATIENT HAD MILD HEMIPARESIS. THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A PARTIAL INFARCTION OF THE RIGHT TRUNCAL GANGLION. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2023, THE PATIENT WAS READMITTED AFTER A FIRST BILATERAL TONIC CLONIC SEIZURE. THE MRI REVEALED AN IMAGE FINDING THAT IS DESCRIBED IN PUBLICATIONS WITH CEREBRAL GRANULOMAS AS A REACTION TO EMBOLIZED HYDROPHILIC POLYMERS FROM MICROWIRES, MICROCATHETERS OR ASPIRATION CATHETERS. THE SUSPECTED FOREIGN BODY GRANULOMAS ALONG THE CORTICAL BORDER WERE FOUND IN THE ANTERIOR CEREBRAL ARTERY (ACA) AND THE ANTERIOR COMMUNICATION ARTERY (ACOM). THERE WAS ALSO EDEMA NOTED. THE PHYSICIAN THEN STARTED METHYLPREDNISOLONE THERAPY WHICH LED TO SI

  Patient problems: Foreign Body Reaction

  MAUDE report 17731903 ↗
• MalfunctionJan 3, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE THE FIRST PASS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE ACE68 OVER THE 3MAXC. THEREFORE, THE PHYSICIAN REMOVED THE 3MAXC AND ACE68 TOGETHER, AND NOTICED THE DISTAL END OF THE ACE68 WAS FRACTURED AND WAS HELD TOGETHER BY A WIRE. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO USE A NEW 3MAXC, THERE WAS NO NOTICEABLE DAMAGE TO THE 3MAXC. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND A NEW 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091748 ↗
• MalfunctionNov 9, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INTRODUCING THE ACE68 THROUGH THE PROXIMAL END OF THE BALLOON GUIDE CATHETER. UPON REMOVAL, IT WAS NOTED THAT THE ACE68 WAS BROKEN IN TWO PIECES AT THE DISTAL END, BUT REMAINED CONNECTED BY THE EXPOSED BRAIDED WIRE. THEREFORE, THE ACE68 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME BALLOON GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765042 ↗
• MalfunctionAug 25, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 TO THE TARGET VESSEL USING THE GUIDE CATHETER AND BEGAN ASPIRATION. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE ACE68 WAS BROKEN AND LEAKING. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND THE SAME NON-PENUMBRA GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299136 ↗
• MalfunctionJul 7, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE ACE68 THROUGH THE DISTAL END OF THE NEURON MAX. THEREFORE, THE ACE68 WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW ACE68 THROUGH THE NEURON MAX; HOWEVER THE SAME ISSUE OCCURRED. THEREFORE, THE ACE68 AND NEURON MAX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132145 ↗
• MalfunctionJul 7, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE ACE68 THROUGH THE DISTAL END OF THE NEURON MAX. THEREFORE, THE ACE68 WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW ACE68 THROUGH THE NEURON MAX; HOWEVER THE SAME ISSUE OCCURRED. THEREFORE, THE ACE68 AND NEURON MAX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132130 ↗
• MalfunctionApr 13, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET LOCATION USING THE ACE68. WHILE REINSERTING THE ACE68 INTO THE NEURON MAX, THE ACE68 FRACTURED AT THE MIDSHAFT. THEREFORE, THE ACE68 AND NEURON MAX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657459 ↗
• MalfunctionFeb 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE ACE68 AND STENT RETRIEVER. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE REMOVING THE ACE68 AND STENT RETRIEVER TO PERFORM A CONTRAST RUN. THE PHYSICIAN DECIDED TO PERFORM ANOTHER PASS USING THE ACE68; HOWEVER, UPON INSPECTION OF THE ACE68, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE ACE68 TO BE WRINKLED AND ACCORDIONED. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER WITH THE SAME STENT RETRIEVER AND NEURON MAX. 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 11353424 ↗