Penumbra System 3MAXCKIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548019949), received between Mar 13, 2019 and Dec 10, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 3MAXC THROUGH A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) TO THE TARGET VESSEL. UPON REMOVAL OF THE 3MAXC AND JETD AFTER AN UNSUCCESSFUL PASS, IT WAS NOTICED THAT THE MARKER BAND OF THE 3MAXC REMAINED IN THE M1 SEGMENT. THE PHYSICIAN THEN MADE 2-3 ATTEMPTS TO RETRIEVE THE BROKEN 3MAXC TIP USING A STENT RETRIEVER; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THE MARKER BAND OF THE 3MAXC REMAINED IN THE PATIENT AND THE PROCEDURE WAS ABORTED. ON (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED; HOWEVER, THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. FURTHERMORE, THE RELATIONSHIP OF THE 3MAXC TO THE PATIENT''S DEATH IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9447729 ↗
• MalfunctionMay 10, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING) PACKAGED WITH THE PENUMBRA SYSTEM 3MAX HI-FLOW KIT. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE LUMEN OF THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WOULD NOT OPEN AND THERE WAS NO ASPIRATION GENERATED AFTER TURNING ON THE TUBING FLOW SWITCH. AFTER FLIPPING THE FLOW SWITCH BACK AND FORTH, ASPIRATION WAS ACHIEVED. IT WAS REPORTED THAT THE TUBING WOULD NOT WORK PROPERLY EVERY TIME. THE PROCEDURE WAS COMPLETED USING THE SAME 3MAXC, TUBING, AND VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599011 ↗
• MalfunctionMar 13, 2019Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX HI-FLOW KIT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A STENT RETRIEVER DEVICE THROUGH TORTUOUS ANATOMY INTO THE TARGET VESSEL USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET 7). UPON REMOVAL OF THE 3MAXC AFTER PLACEMENT OF THE STENT RETRIEVER DEVICE, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE 3MAXC HAD STRETCHED AND BROKEN INSIDE THE JET 7. THEREFORE, THE DISTAL TIP OF THE 3MAXC WAS ASPIRATED BACK INTO THE CANISTER. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC AND THE SAME JET 7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417422 ↗