Penumbra System 5MAXACE064KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548016481), received between Mar 31, 2016 and May 9, 2017 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (11 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.

• InjuryMay 9, 2017Break; Fracture; Material Separation; Break; Fracture; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND A PENUMBRA SYSTEM ACE 64 HI-FLOW KIT. DURING THE PROCEDURE, THE PHYSICIAN USED THE 3MAX AND THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) FOR THE INITIAL PASS TO REMOVE THROMBUS. DURING THE SECOND PASS, THE 3MAX BECAME LODGED INTO CLOT AND WAS STUCK IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN THEN ATTEMPTED TO REMOVE BOTH THE 3MAX AND ACE 64. HOWEVER, THE 3MAX WAS SO LODGED THAT ITS TIP BROKE OFF COMPLETELY. IT WAS ALSO REPORTED THAT THE ACE 64 SNAPPED IN HALF APPROXIMATELY FIFTEEN CENTIMETERS FROM THE DISTAL TIP BUT WAS SUCCESSFULLY SNARED OUT. HOWEVER, AFTER SEVERAL FAILED ATTEMPTS TO SNARE THE TIP OF THE 3MAX OUT, THE PHYSICIAN DECIDED TO LEAVE THE TIP OF THE 3MAX IN THE PATIENT AND STOP THE PROCEDURE. THE PHYSICIAN BELIEVED THAT CONTINUING THE PROCEDURE COULD CAUSE MORE HARM THAN GOOD. PARTIAL REPERFUSION WAS ACHIEVED BUT THE PATIENT STILL HAD CLOT REMAINING IN THE VESSEL. AS OF (B)(6) 2017, THE PATIENT STILL HAD A LARGE MCA INFARCT AND MASS EFFECT. THE MASS EFFECT WAS CAUSED BY NOT BEING ABLE TO SUCCESSFULLY REM

  Patient problems: Embolus; Infarction, Cerebral

  MAUDE report 6554065 ↗
• MalfunctionFeb 23, 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 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED ACE 64 WAS NOTICED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 6352866 ↗
• MalfunctionJan 18, 2017Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 HI-FLOW KIT (KIT). DURING THE PROCEDURE, THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) BECAME BADLY KINKED AND ALMOST FRACTURED AT THE STRAIN RELIEF NEAR THE HUB. HOWEVER, THE PROCEDURE WAS STILL COMPLETED USING THE DAMAGED ACE 64, WITH THE DAMAGED PORTION OUTSIDE OF THE PATIENT¿S BODY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6260833 ↗
• MalfunctionDec 20, 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) HAD TWO KINKS UPON REMOVAL FROM THE PACKAGING. THE KINKED ACE 64 WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 6191572 ↗
• MalfunctionOct 18, 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 AT THE HUB UPON REMOVAL FROM ITS DISPENSER HOOP. 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 6036938 ↗
• MalfunctionSep 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 SCRUB TECHNOLOGIST NOTICED THAT THE MIDDLE OF PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS SEVERELY 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 5957334 ↗
• MalfunctionAug 8, 2016Crack; Device Damaged Prior to Use; Out-Of-Box Failure; Crack; 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 CRACKED AT THE HUB UPON REMOVAL FROM THE PACKAGING. THE CRACKED 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 5854669 ↗
• MalfunctionJul 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 THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM ITS 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 5800418 ↗
• MalfunctionJul 12, 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 PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS FRACTURED UPON REMOVAL FROM ITS PACKAGING. THE FRACTURED 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 5788254 ↗
• MalfunctionJul 9, 2016Unraveled Material; Device Damaged Prior to Use; Out-Of-Box Failure; Unraveled Material; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 KIT AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING PREPARATION FOR THE PROCEDURE, AFTER REMOVING THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) FROM ITS PACKAGING, THE HOSPITAL STAFF NOTICED THAT THE ACE64 WAS UNRAVELED. THE UNRAVELED ACE 64 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. A NEW ACE 64 WAS THEN OPENED FOR THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY ATTEMPTED TO USE A NINETY CENTIMETER NEURON MAX FOR A GROIN ACCESS; HOWEVER, THE NEURON MAX WAS REMOVED FROM THE PATIENT DUE TO TORTUOSITY. THERE WAS NO REPORTED DEFICIENCY WITH THIS NEURON MAX. THE PHYSICIAN THEN OPENED AND USED AN EIGHTY CENTIMETER NEURON MAX FOR THE PROCEDURE. HOWEVER, AFTER COMPLETING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE NEURON MAX FROM THE PATIENT, THE PATIENT EXPERIENCED A LOT OF VASOSPASM. SUBSEQUENTLY, THE PHYSICIAN HAD DIFFICULTY REMOVING THE NEURON MAX AND IT BECAME STUCK IN THE RADIAL ARTERY OF THE PATIENT'S ARM. THE PHYSICIAN PULLED ON THE NEURON MAX BUT IT BROKE INSIDE THE PATIENT'S ARM. THEREFORE, THE PHYSICIAN REQUIRED A SNA

  Patient problems: No Patient Involvement

  MAUDE report 5780720 ↗
• MalfunctionJul 1, 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 64 REPERFUSION CATHETER (ACE 64) WAS KINKED IN ITS 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 5764987 ↗
• MalfunctionJun 27, 2016Break; Kinked; Physical Resistance; Break; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS (3MAX) AND A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE ADVANCING AN INITIAL 3MAX THROUGH THE ACE 64 WITHOUT USING AN INNER GUIDE WIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE 3MAX BROKE OFF INTRACRANIALLY. THE PORTION OF THE 3MAX THAT BROKE OFF WAS IN THE DISTAL SEGMENT, APPROXIMATELY 3-4 INCHES FROM THE DISTAL TIP. CONSEQUENTLY, THE PHYSICIAN REQUIRED A STENT RETRIEVER TO RETRIEVE THE BROKEN 3MAX. A NEW 3MAX WAS THEN OPENED AND USED WITH THE SAME ACE 64 FOR THE SECOND PASS. HOWEVER, FOR THE SECOND TIME, WHILE ADVANCING THE NEW 3MAX THROUGH THE ACE 64 WITHOUT USING A GUIDE WIRE, THE PHYSICIAN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, BOTH THE 3MAX AND ACE 64 BECAME KINKED AND EVENTUALLY BROKE. THEREFORE, THE 3MAX AND ACE 64 WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CATHETER. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY BUT THAT DID NOT CAUSE THE REPORTED ISSUES. HOWEVER, IT SHOULD BE NOTED THAT THE PHYSICIAN WAS NOT USING AN INNER GUIDE WIRE WHILE ADVANCING THE PENUMBRA D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5753751 ↗
• MalfunctionJun 9, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, WHILE REMOVING THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) FROM ITS PACKAGING, THE PHYSICIAN INADVERTENTLY KINKED THE DISTAL END OF THE ACE 64. 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 KIT.

  Patient problems: No Patient Involvement

  MAUDE report 5710951 ↗
• MalfunctionJun 7, 2016Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 64 KIT (KIT). DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) THROUGH ANOTHER MANUFACTURER'S SHEATH AND THEN ADVANCED THE ACE 64 TO THE FACE OF THE CLOT. NEXT, THE PENUMBRA HI-FLOW ASPIRATION TUBING (TUBING) WAS CONNECTED AND ASPIRATION WAS INITIATED. AS THE PHYSICIAN PULLED THE ACE 64 BACK FROM THE CLOT, THE HUB SEPARATED FROM THE ACE 64. THE PHYSICIAN IMMEDIATELY TURNED OFF THE ASPIRATION, DISCONNECTED THE TUBING AND REMOVED THE ACE 64 FROM THE PATIENT. ANOTHER KIT WAS OPENED AND A NEW ACE 64 WAS INTRODUCED TO THE FACE OF THE CLOT. THE SAME TUBING WAS CONNECTED AND ASPIRATION WAS RESTARTED. AS THE PHYSICIAN BEGAN TO ASPIRATE, HE HAD TROUBLE APPLYING ENOUGH FORCE ON THE TUBING TO GET IT TO STAY ON. AFTER MUCH EFFORT, THE PHYSICIAN WAS ABLE TO GET THE FLOW SWITCH COMPLETELY TO THE "ON" POSITION. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES AND THE CLOT WAS REMOVED USING SOLUMBRA TECHNIQUE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5704614 ↗
• MalfunctionMay 31, 2016Leak/Splash; Aspiration Issue; Leak/Splash; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE ACE 64 WAS ASPIRATING BACK AIR AND WAS LATER LEAKING NEAR THE HUB. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT THE USE OF A NEW ACE 64 OR ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5689114 ↗
• MalfunctionMay 24, 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 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64 KIT.

  Patient problems: No Patient Involvement

  MAUDE report 5677156 ↗
• MalfunctionMay 23, 2016Leak/Splash; Material Separation; Aspiration Issue; Leak/Splash; Material Separation; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 KIT (ACE 64). DURING THE ENTIRE PROCEDURE, THE PHYSICIAN NOTICED THAT THE ACE 64 WAS SEPARATED AROUND THE HUB AND SUBSEQUENTLY, IT WAS LEAKING BELOW THE HUB AND SUCKING BACK AIR. HOWEVER, THE PROCEDURE WAS COMPLETED USING THE SAME ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5671506 ↗
• MalfunctionApr 8, 2016Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED OTHER MANUFACTURER'S DEVICES AND THE ACE 64 INTO THE PATIENT AND ATTEMPTED TO INJECT SALINE THROUGH THE ACE 64. HOWEVER, WHILE INJECTING SALINE, THE PROXIMAL PORTION OF THE ACE 64 BECAME UNRAVELED. THE ACE 64 AND THE OTHER MANUFACTURER'S DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64 AND OTHER MANUFACTURERS'' DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5563247 ↗
• MalfunctionMar 31, 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 A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER KIT (ACE 64) WAS KINKED UPON REMOVAL FROM THE PACKAGING 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 5538294 ↗