ACERecalls & reported problems across all models
Penumbra, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 292
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 6 models of ACE by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 292 adverse event reports in the FDA's MAUDE database, received between Sep 3, 2015 and Mar 7, 2025 — classified as 21 injuries, 271 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (76 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 ACE problems
Device problems
- Device Damaged Prior to Use76
- Break67
- Physical Resistance/Sticking67
- Material Deformation61
- Out-Of-Box Failure53
- Kinked44
- Fracture31
- Stretched27
Patient problems
- No Consequences Or Impact To Patient148
- No Patient Involvement91
- No Clinical Signs, Symptoms or Conditions43
- No Known Impact Or Consequence To Patient5
- Device Embedded In Tissue or Plaque4
- Hemorrhage/Blood Loss/Bleeding3
- Vascular Dissection3
- Vasoconstriction3
ACE models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACE 5MAXACE068KITCATHETER, THROMBUS RETRIEVER170 reports
- ACE 5MAXACE068CATHETER, THROMBUS RETRIEVER76 reports
- ACE 5MAXACE064CATHETER, THROMBUS RETRIEVER19 reports
- ACE 5MAXACE064KITCATHETER, THROMBUS RETRIEVER15 reports
- ACE 5MAXACE068KIT-RCATHETER, THROMBUS RETRIEVER10 reports
- ACE 5MAXACE068-RCATHETER, THROMBUS RETRIEVER2 reports
Recent ACE adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 16, 2023Fracture; Difficult to Advance; Physical Resistance/Sticking; Fracture; Difficult to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN STEAM SHAPED THE DISTAL END OF THE ACE68. NEXT, WHILE ADVANCING THE ACE68 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND AFTER PARTIALLY ADVANCING THE ACE68 OUT OF THE DISTAL END OF THE SHEATH, THE ACE68 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE ACE68. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS FRACTURED AT THE DISTAL END AND CONNECTED BY A WIRE. THEREFORE, THE ACE68 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17144595 ↗MalfunctionApr 4, 2023Break; Break
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX IN THE PATIENT. WHILE ADVANCING THE ACE68 INTO THE NEURON MAX, THE PHYSICIAN FRACTURED THE ACE68 AT THE PROXIMAL END NEAR THE HUB. SUBSEQUENTLY, THE ACE68 WAS LEAKING AT THE FRACTURED PART OUTSIDE OF THE PATIENT, JUST BEFORE CONNECTION WITH THE ASPIRATION SYSTEM. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16677731 ↗MalfunctionJan 20, 2023Break; Break
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A PENUMBRA ENGINE (ENGINE), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 OVER THE VELOCITY. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. THEREFORE, THE PHYSICIAN COULD ONLY ADVANCE THE RED72 PAST THE PROXIMAL TORTUOSITY AND TORTUOSITY OF THE SUPRACLINOID ICA. HOWEVER, THE PHYSICIAN COULD NOT ADVANCE THE RED72 PAST THE OPHTHALMIC SEGMENT. THEREFORE, THE RED72 WAS REMOVED FROM THE PATIENT. NEXT, THE PHYSICIAN ADVANCED THE ACE68 OVER THE VELOCITY TO THE TARGET LOCATION AND COMPLETED ASPIRATION. UPON REMOVAL, IT WAS NOTED THE ACE68 WAS BROKEN AT THE DISTAL PART. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE DISTAL PART OF THE ACE68 FROM THE PATIENT; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE DISTAL PORTION OF THE ACE68 WAS LEFT IN THE PATIENT'S VESSEL.
Patient problems: Foreign Body In Patient
MAUDE report 16219563 ↗MalfunctionJan 6, 2023Physical Resistance/Sticking
MECHANICAL THROMBECTOMY PROCEDURE WAS BEING PERFORMED. PHYSICIAN ADVANCED THROUGH THE GUIDE CATHETER A SOFIA 5 FRENCH ASPIRATION CATHETER USING THE SNAKE TECHNIQUE WITH THE .035 ANGLE GLIDE GUIDEWIRE. PHYSICIAN ADVANCED THIS THROUGH THE PROXIMAL TORTUOSITY OF THE ICA (INTERNAL CAROTID ARTERY) AND THROUGH THE SUPRACLINOID SEGMENT TO THE AREA OF THE THROMBUS. PHYSICIAN THEN PERFORMED ASPIRATION. THIS WAS PERFORMED IN THE STANDARD FASHION AND AFTER ADEQUATE ASPIRATION, PHYSICIAN BEGAN GENTLY REMOVING THE ASPIRATION CATHETER WHILE ASPIRATING ON THE GUIDE CATHETER ALSO. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED. CONTINUED THROMBUS IN THE DISTAL M1 SEGMENT WITH NO CHANGE VERSUS BASELINE WAS OBSERVED. GIVEN THE POTENTIAL FOR RECALCITRANT CLOT AND WHAT FELT LIKE FIRM CLOT VIA THE ASPIRATION CATHETER, PHYSICIAN ATTEMPTED TO USE THE PENUMBRA RED .072 ASPIRATION CATHETER. THIS WAS ADVANCED OVER A VELOCITY MICROCATHETER ALONG WITH A SYNCHRO 2 STANDARD MICRO WIRE USING ROADMAP ANGIOGRAPHY. PHYSICIAN WAS ABLE TO ADVANCE THE SYSTEM PAST THE PROXIMAL TORTUOSITY BUT GIVEN THE PROXIMAL TORTUOSITY AND TORTUOSITY OF THE SUPRACLINOID ICA, PHYSICIAN WAS UNABLE TO ADVANCE THE .072 ASPIRATION CATHETER PAST THE
Patient problems: Obstruction/Occlusion
MAUDE report 16111369 ↗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 ↗MalfunctionJun 30, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE68 THROUGH THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN KINKED AND BROKE THE ACE68 ON THE PROXIMAL END, FIVE CENTIMETERS FROM THE HUB. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14881109 ↗MalfunctionMar 8, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE68 THROUGH THE SHEATH. IT WAS REPORTED THAT THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE THE ACE68 THROUGH THE SHEATH BUT THE ATTEMPTS WERE UNSUCCESSFUL. THEREFORE, THE ACE68 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS FRACTURED APPROXIMATELY 20 CENTIMETERS FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691052 ↗MalfunctionDec 6, 2021Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER, A GUIDEWIRE, AND A NON-PENUMBRA HEMOSTASIS VALVE. WHILE PREPARING THE ACE68 ON THE BACK TABLE, THE PHYSICIAN REPORTED THAT THE ACE68 WAS KINKED AT THE DISTAL END. HOWEVER, THE PHYSICIAN PROCEEDED TO USE A HEAT GUN TO SHAPE THE ACE68 ONE CENTIMETER FROM THE DISTAL TIP. DURING THE PROCEDURE, AFTER COMPLETING ONE PASS, THE ACE68 WAS RETRACTED UNDER NEGATIVE PRESSURE. WHILE RE-ADVANCING THE ACE68 INTO THE HEMOSTASIS VALVE TO MAKE ANOTHER PASS, RESISTANCE WAS ENCOUNTERED. THE ACE68 WAS ADVANCED AND RETRACTED SEVERAL TIMES IN THE HEMOSTASIS VALVE BEFORE IT WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE ACE68 WAS BROKEN AND CONNECTED BY A WIRE TO THE PROXIMAL SHAFT. HOWEVER, THE PROCEDURE WAS COMPLETED AT THIS POINT 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 12945808 ↗MalfunctionNov 30, 2021Stretched; Stretched
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), 8F SHEATH, AND A 8F BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 INTO THE TARGET LOCATION AND USED A 40CC SYRINGE TO ASPIRATE CLOT. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT FEELING TYPICAL CLOT ASPIRATION THROUGH THE ACE68 AFTER SEVERAL ATTEMPTS. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE ACE68 AND FOUND THE DISTAL END TO BE STRETCHED. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA CATHETER WITH THE SAME SHEATH AND BALLOON GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12903498 ↗InjuryNov 16, 2021Adverse 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 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDING CATHETER, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, AFTER THE ACE68 PASSED THROUGH THE LESION SIX TIMES, AN INTRACEREBRAL HEMORRHAGE WAS NOTICED. THE PHYSICIAN DECIDED TO STOP THE THROMBECTOMY PROCEDURE AT THIS POINT. IT WAS REPORTED THAT NO ADDITIONAL ACTION WAS TAKEN TO TREAT THE HEMORRHAGE. THERE WAS NO ADDITIONAL ADVERSE EFFECT TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12819715 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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