Penumbra System 5MAXACE068KIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548017532), received between Aug 10, 2016 and Nov 22, 2016 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED UPON OPENING THE PACKAGING OF THE PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). THE KINKED ACE 68 WAS NOTICED PRIOR TO USE AND THEREFORE, THE ACE 68 WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6123009 ↗
• MalfunctionOct 26, 2016Crack; Device Damaged Prior to Use; Out-Of-Box Failure; Crack; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) AND A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60). DURING THE PROCEDURE, UPON OPENING THE ACE 68 AND ACE 60 PRODUCT BOXES, THE HOSPITAL STAFF NOTICED THEY WERE CRACKED WITHIN THEIR PRODUCT PACKAGINGS. THE CRACKED ACE 68 AND ACE 60 WERE FOUND PRIOR TO USED AND THEREFORE WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 60.

  Patient problems: No Patient Involvement

  MAUDE report 6057978 ↗
• MalfunctionSep 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 HOSPITAL STAFF NOTICED THAT THE MIDSECTION OF 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 5971698 ↗
• MalfunctionSep 13, 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 HOSPITAL FELLOW NOTICED THAT THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS BROKEN IN HALF UPON REMOVAL FROM ITS DISPENSER HOOP. THE ACE 68 BROKE IN HALF PRIOR TO USE AND THEREFORE WAS NOT USED IN THE PROCEDURE. IT IS UNCLEAR WHETHER OR NOT THE FELLOW CAUSED THE DAMAGE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64).

  Patient problems: No Patient Involvement

  MAUDE report 5946834 ↗
• MalfunctionSep 6, 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 THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS KINKED. THE KINKED ACE 68 WAS FOUND 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 5930290 ↗
• MalfunctionAug 23, 2016Retraction Problem; Physical Resistance; Material Deformation; Retraction Problem; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT. DURING THE PROCEDURE, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S SHEATH UTILIZING A TRIAXIAL (PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND ANOTHER MANUFACTURER'S GUIDEWIRE). THE PATIENT HAD TORTUOUS ANATOMY WITH A 360 DEGREE LOOP IN THE DISTAL ICA. ANOTHER MANUFACTURER'S STENT DEVICE WAS DEPLOYED IN THE THROMBUS LOCATED IN THE DISTAL M1 SEGMENT AND THE ACE 68 WAS ADVANCED TO THE MID M1 SEGMENT. THE PHYSICIAN THEN USED THE SOLUMBRA TECHNIQUE AND PULLED THE STENT DEVICE THROUGH THE ACE 68 WITHOUT AN ISSUE; HOWEVER, A MINIMAL AMOUNT OF THROMBUS WAS CAPTURED. THE PHYSICIAN THEN ADVANCED A SMALLER STENT DEVICE FROM THE M2 SEGMENT COMING BACK TO THE M1 SEGMENT FOR THE SECOND PASS. WHILE ATTEMPTING TO PULL THE STENT DEVICE BACK INTO THE ACE 68, THE PHYSICIAN EXPERIENCED SIGNIFICANT RESISTANCE AND WAS UNABLE TO PULL THE STENT INTO THE ACE 68. THEREFORE, THE PHYSICIAN RETRACTED BOTH THE STENT AND THE ACE 68 BACK INTO THE ICA AND WAS THEN ABLE TO PULL THE STENT DEVICE BACK INTO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5898591 ↗
• MalfunctionAug 10, 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 REPERFUSION CATHETER (ACE 68) WAS KINKED UPON REMOVAL FROM THE 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 KIT.

  Patient problems: No Patient Involvement

  MAUDE report 5867198 ↗