ACE 5MAXACE068-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948022843), received between Jan 6, 2023 and Jan 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗