Penumbra System 5MAXACE068KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548016597), received between Sep 26, 2016 and Feb 5, 2018 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (12 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.

• MalfunctionFeb 5, 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 STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WAS KINKED UPON REMOVAL FROM THE PACKAGING OF THE PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). THE DAMAGED ACE68 WAS FOUND PRIOR TO USE AND THEREFORE; IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE68.

  Patient problems: No Patient Involvement

  MAUDE report 7240823 ↗
• MalfunctionOct 10, 2017Kinked; Aspiration Issue; Kinked; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA)/MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ISCHEMIC STROKE USING PENUMBRA SYSTEM ACE 68 HI-FLOW KITS (KITS). DURING THE PROCEDURE, WHILE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE ASPIRATION STOPPED WORKING; THEREFORE, THE ACE68 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS KINKED AROUND THE MID-SHAFT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW KIT AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6937898 ↗
• MalfunctionMar 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 3MAX INTO THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68), THE PHYSICIAN DID NOT MENTION FEELING ANY RESISTANCE; HOWEVER, THE 3MAX BROKE INTO TWO PIECES. THEREFORE, THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 3MAX AND A NEW KIT. IT SHOULD BE NOTED THAT THERE WERE NO REPORTED DAMAGES TO THE ACE 68. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424726 ↗
• MalfunctionMar 2, 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 PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED WHEN THE TECHNOLOGIST HANDED IT TO HIM. THE KINKED ACE 68 WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 6373706 ↗
• MalfunctionJan 26, 2017Kinked; Kinked

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) KINKED UPON REMOVAL FROM THE PACKAGING OF THE PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). THE ACE 68 BECAME KINKED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 6281611 ↗
• MalfunctionJan 25, 2017Collapse; Collapse

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68). DURING THE PROCEDURE, THE TIP OF THE ACE 68 BECAME COLLAPSED AFTER CONTINUED USE. THEREFORE, THE ACE 68 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6276074 ↗
• MalfunctionJan 13, 2017Break; 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 THAT WHEN THE PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT) WAS OPENED, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS BROKEN BEFORE IT WAS TAKEN OUT OF THE PACKAGING. THE BROKEN ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6251695 ↗
• MalfunctionJan 11, 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 PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) BECAME KINKED UPON REMOVAL FROM ITS PACKAGING. THE KINKED ACE 68 WAS FOUND PRIOR TO USE; THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 6242582 ↗
• MalfunctionJan 5, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Defective Device; Device Damaged Prior to Use; Out-Of-Box Failure; Defective Device

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE BRAIDING AT THE END OF A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) DID NOT LOOK ¿CORRECT¿ UPON REMOVING IT FROM THE PACKAGING. THE ACE 68 WAS NOTICED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6226372 ↗
• MalfunctionDec 13, 2016Material Separation; Stretched; Mechanical Jam; Material Separation; Stretched; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). DURING THE PROCEDURE, WHILE FOLLOWING PROTOCOL, THE PHYSICIAN REMOVED THE OTHER MANUFACTURER'S STENT RETRIEVER AND THEN ATTEMPTED TO REMOVE THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68). WHILE RETRACTING THE ACE 68, THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE; HOWEVER, THE ACE 68 BECAME STUCK IN THE ROTATING HEMOSTASIS VALVE (RHV) AND BEGAN TO STRETCH THEN SEPARATE. THE PHYSICIAN BELIEVED THAT THE RHV WAS TOO TIGHT. THEREFORE, THE RHV WAS LOOSENED AND THE ACE 68 WAS ABLE TO BE REMOVED INTACT. THE PROCEDURE WAS THEN COMPLETED USING A NEW ACE 68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6170499 ↗
• MalfunctionNov 22, 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 PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED WHILE STILL IN ITS PACKAGING HOOP. THE KINKED ACE 68 WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT).

  Patient problems: No Patient Involvement

  MAUDE report 6123305 ↗
• MalfunctionNov 22, 2016Fracture; Stretched; Unraveled Material; Fracture; Stretched; Unraveled Material

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS FRACTURED AT THE MID-SHAFT AND ITS INNER CORE WAS UNRAVELED AND STRETCHED UPON REMOVAL FROM THE PACKAGING OF THE PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). THE DAMAGED ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 6121990 ↗
• MalfunctionNov 22, 2016Device Damaged Prior to Use; Out-Of-Box Failure; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS DAMAGED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68. PLEASE NOTE THAT THE DATE OF EVENT WAS NOT PROVIDED. THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 6120831 ↗
• MalfunctionNov 16, 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 TWO PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETERS (ACE 68) WERE KINKED UPON REMOVAL FROM THEIR DISPENSER HOOPS. THE KINKED ACE 68 DEVICES WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 6106466 ↗
• MalfunctionNov 16, 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 TWO PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETERS (ACE 68) WERE KINKED UPON REMOVAL FROM THEIR DISPENSER HOOPS. THE KINKED ACE 68 DEVICES WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 6106465 ↗
• MalfunctionOct 19, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  WHILE PREPARING A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT) FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED AT THE HUB UPON REMOVAL FROM ITS DISPENSER HOOP. THE KINKED ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64).

  Patient problems: No Patient Involvement

  MAUDE report 6038743 ↗
• MalfunctionOct 4, 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 TECHNOLOGIST NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED UPON REMOVAL FROM ITS PACKAGING. THE KINKED ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 5998477 ↗
• MalfunctionSep 26, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER KIT. DURING THE PROCEDURE, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS LOCKED INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND MOVED IN A NON LINEAR MANOR TO THE SYSTEM WHICH RESULTED IN A KINK AT THE PROXIMAL SHAFT. THEREFORE, THE ACE 68 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5978021 ↗
• MalfunctionSep 26, 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 68 HI-FLOW KIT WAS KINKED UPON REMOVAL FROM ITS DISPENSER HOOP. THE KINKED ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.

  Patient problems: No Patient Involvement

  MAUDE report 5977471 ↗