ACE 5MAXACE064KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548016467), received between Aug 2, 2016 and Dec 26, 2019 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS REPORTED THE PATIENT HAD FIBROMUSCULAR DYSPLASIA (FMD) AND A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE CLOT WAS INITIALLY REMOVED USING THE 3MAXC, JET7, AND NEURON MAX, BUT THE VESSEL RE-CLOTTED; THEREFORE, THE PHYSICIAN DECIDED TO USE THE SAME 3MAXC AND NEURON MAX WITH THE ACE64 FOR A SECOND TREATMENT. WHILE ADVANCING THE 3MAXC AND ACE64 THROUGH THE NEURON MAX IN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE TIP OF THE ACE64 "BUCKLED" AND PERFORATED THE CAROTID TERMINUS; THEREFORE, THEY WERE REMOVED. SUBSEQUENTLY, A FISTULA WAS FORMED WITH THE CAVERNOUS SINUS. THE PHYSICIAN THEN ATTEMPTED TO PERFORM A VESSEL SACRIFICE BUT WAS UNABLE TO CROSS THE LESION. TO TREAT THE VESSEL PERFORATION, COILS WERE PLACED IN THE CAVERNOUS SINUS. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE, AND THE PHYSICIAN WILL RE-ATTEMPT TO PERFORM A VESSEL SACRIFICE AT A

  Patient problems: Vascular Dissection

  MAUDE report 9521811 ↗
• MalfunctionFeb 22, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT), THE PHYSICIAN WAS UNABLE TO ADVANCE A GUIDEWIRE THROUGH THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) AT THE BACK TABLE PRIOR TO INSERTION INTO THE PATIENT. UPON INSPECTION, A KINK WAS FOUND AT THE PROXIMAL END OF THE ACE64 AND THEREFORE, NOT USED. 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 8362818 ↗
• MalfunctionSep 20, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) AND A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) WERE KINKED AT THE HUB AND BEGAN TO UNRAVEL UPON REMOVAL FROM THEIR PACKAGING. THE DAMAGE TO THE 5MAX ACE AND THE ACE64 OCCURRED PRIOR TO USE AND, THEREFORE, THE DEVICES WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE64.

  Patient problems: No Patient Involvement

  MAUDE report 7894801 ↗
• MalfunctionJun 21, 2018Kinked; 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 TECHNICIAN NOTED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) WAS KINKED UPON REMOVAL FROM THE PACKAGING OF THE PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT). THE DAMAGE TO THE ACE64 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE64.

  Patient problems: No Patient Involvement

  MAUDE report 7625670 ↗
• InjuryMay 29, 2018Break; Fracture; Material Separation; Break; Fracture; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT). DURING THE PROCEDURE, THE TIP OF THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) BROKE OFF WITHIN THE INTERNAL CAROTID ARTERY OF THE PATIENT AFTER BEING ADVANCED THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE PHYSICIAN, THEREFORE, USED A RETRIEVAL DEVICE TO REMOVE THE TIP OF THE ACE64. THE PROCEDURE WAS THEN COMPLETED USING THE SAME NEURON MAX AND A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550883 ↗
• InjuryApr 10, 2018Break; Physical Resistance; Break; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON MAX OVER A GUIDEWIRE WITHIN THE ICA. IT WAS REPORTED THAT THE PATIENT¿S VESSELS WERE ELONGATED AND CALCIFIED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE ACE64 AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) OVER THE GUIDEWIRE WITHIN THE NEURON MAX. THE 3MAXC ADVANCED WITH NO ISSUE; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE64, AND THE ACE64 BECAME STUCK; THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE IT. WHILE RETRACTING, THE TIP OF THE ACE64 BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE TIP OF THE ACE64 USING A SNARE DEVICE, HOWEVER WAS UNSUCCESSFUL. THE TIP OF THE ACE64 WAS THEREFORE LEFT IN THE PATIENT''S ICA, AND THE NEURON MAX AND 3MAXC WERE REMOVED FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE NEURON MAX WAS KINKED APPROXIMATELY 20 CENTIMETERS PROXIMAL OF THE TIP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412779 ↗
• MalfunctionFeb 8, 2018Break; Unraveled Material; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Unraveled Material; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THAT A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) WAS BROKEN IN HALF AND UNRAVELED. THE DAMAGE TO THE ACE64 OCCURRED PRIOR TO USE, AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68).

  Patient problems: No Patient Involvement

  MAUDE report 7255938 ↗
• MalfunctionNov 10, 2017Stretched; Device Damaged Prior to Use; Out-Of-Box Failure; Stretched; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNICIAN OPENED THE PACKAGING OF THE PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT) AND THEN THE PHYSICIAN REMOVED THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) FROM THE PACKAGING. UPON REMOVAL FROM THE PACKAGING, THE PHYSICIAN NOTICED THAT THE ACE64 WAS STRETCHED AT THE MID SHAFT AND THAT THE INNER COIL COULD BE SEEN. THE DAMAGED ACE64 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA BALLOON CATHETER AND STENT RETRIEVER DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7021184 ↗
• MalfunctionApr 18, 2017Bent; Out-Of-Box Failure; Device Handling Problem; Bent; Out-Of-Box Failure; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE RADIOLOGIC TECHNOLOGIST HAD DIFFICULTY WHILE ATTEMPTING TO REMOVE THE PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT) TUBING FLOW SWITCH. IT WAS REPORTED THAT THE RADIOLOGIC TECHNOLOGIST HANDS WERE SLIPPERY AND THE SWITCH DID NOT COME OFF EASILY. CONSEQUENTLY, THE TUBING FLOW SWITCH BECAME BENT. THE TUBING FLOW SWITCH BENT PRIOR TO USE AND THEREFORE, THE TUBING WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 64 HI-FLOW KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6500234 ↗
• MalfunctionApr 12, 2017Kinked; 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 AT THE HUB UPON REMOVAL FROM THE PACKAGING OF THE PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT). THE DAMAGED ACE 64 WAS FOUND PRIOR TO USE AND THEREFORE, THE ACE 64 WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6487987 ↗
• InjuryMar 15, 2017Adverse 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 KIT. DURING THE PROCEDURE, WHILE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) DURING THE RECANALIZATION OF THE LEFT M1, VASOSPASMS OCCURRED IN THE PATIENT. THE PATIENT WAS TREATED WITH INTRA-ARTERIAL NIMOTOP AND THE VASOSPASMS COMPLETELY RESOLVED. THE VASOSPASMS WERE ADJUDICATED TO BE A NON-SERIOUS EVENT WITH A PROBABLE RELATIONSHIP TO THE ACE64.

  Patient problems: Vasoconstriction

  MAUDE report 6407410 ↗
• MalfunctionNov 21, 2016Fracture; 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 A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS SLICED INTO TWO PIECES UPON REMOVAL FROM THE PACKAGING. THE FRACTURED ACE64 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THIS PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER TREATMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6118905 ↗
• MalfunctionNov 7, 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 PHYSICIAN NOTICED THE DISTAL TIP OF A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) BECAME DAMAGED WHILE REMOVING IT FROM THE PACKAGING. UPON INSPECTION, THE TIP OF THE ACE 64 WAS FOUND LOOSE AND AFTER FURTHER INSPECTION, THE DISTAL TIP SEPARATED FROM THE REST OF THE ACE 64. THE TIP OF THE ACE 64 BROKE PRIOR TO USE AND THEREFORE THE ACE 64 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 6084337 ↗
• MalfunctionSep 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 IN THE BASILAR ARTERY, THE PHYSICIAN NOTICED THAT THE MIDDLE SHAFT OF THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64 KIT.

  Patient problems: No Patient Involvement

  MAUDE report 5938133 ↗
• MalfunctionAug 2, 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 PACKAGING. THE KINKED ACE 64 WAS FOUND 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 5842058 ↗