Penumbra System 4MAXCKITRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548016740), received between Mar 22, 2017 and Aug 25, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND PENUMBRA SYSTEM MAX 4 REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, IT WAS REPORTED THAT A 3MAXC AND A 4MAXC BECAME STRETCHED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365964 ↗
• MalfunctionAug 18, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA), LEFT MIDDLE CEREBRAL ARTERY (M1, M2) AND LEFT ANTERIOR CEREBRAL ARTERY (A2) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), A NON-PENUMBRA CATHETER, A NON-PENUMBRA STENT RETRIEVER AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE VELOCITY WITHIN THE NON-PENUMBRA CATHETER AND THE STENT RETRIEVER INTO THE LEFT M1 WITH M2 AS THE TARGET LOCATION. THEREFORE, THE VELOCITY AND THE CATHETER WERE REMOVED AND THE SECOND VELOCITY WAS OPENED ALONG WITH 4MAXC. WHILE ADVANCING THE 4MAXC WITH THE SECOND VELOCITY USING A GUIDEWIRE, THE PHYSICIAN ENCOUNTERED RESISTANCE AND HAD DIFFICULTY ADVANCING THE SECOND VELOCITY AS WELL. HOWEVER, THE PHYSICIAN WAS ABLE TO PERFORM THROMBECTOMY IN THE M2 SUCCESSFULLY. THE PHYSICIAN THEN TRIED TO ADVANCE THE VELOCITY TO THE NEXT TARGET LOCATION (LEFT A2); HOWEVER HE AGAIN HAD DIFFICULTY ADVANCING THE VELOCITY TO THE TARGET LOCATION. THEREFORE, THE VELOCITY WAS REMOVED AND REPLACED BY A NON-PENUMBRA MICROCATHETER. AFTER REMOVAL, THE PHYSICIAN NOTED THAT THE PROXIMAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338986 ↗
• MalfunctionMay 4, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE INSERTING A 4MAXC INTO THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE 4MAXC. UPON REMOVAL, IT WAS NOTICED THAT APPROXIMATELY TWENTY CENTIMETERS FROM THE DISTAL END OF THE 4MAXC WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768095 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, ONE PASS WAS COMPLETED WITH THE 4MAXC. AFTER RE-ADVANCING THE 4MAXC AND FACING THE CLOT, THE PHYSICIAN NOTICED EXCESSIVE BLOOD BEING ASPIRATED. THE 4MAXC WAS PULLED BACK AND THE PHYSICIAN FOUND THAT THE DISTAL MIDDLE THIRD OF THE 4MAXC HAD FRACTURED AND WAS CONNECTED BY A SINGLE WIRE. THEREFORE, THE 4MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543658 ↗
• MalfunctionDec 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN MADE A COUPLE OF ATTEMPTS TO INSERT THE 4MAXC INTO THE NEURON MAX; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL PORTION OF THE 4MAXC AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO INSERT A NEW 4MAXC INTO THE NEURON MAX; HOWEVER, THE SAME RESISTANCE ISSUE OCCURRED AND, THEREFORE, THE 4MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC 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 9526257 ↗
• MalfunctionDec 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN MADE A COUPLE OF ATTEMPTS TO INSERT THE 4MAXC INTO THE NEURON MAX; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL PORTION OF THE 4MAXC AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO INSERT A NEW 4MAXC INTO THE NEURON MAX; HOWEVER, THE SAME RESISTANCE ISSUE OCCURRED AND, THEREFORE, THE 4MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC 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 9526245 ↗
• MalfunctionJun 27, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M2 AND M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERS (4MAXC)S. DURING THE PROCEDURE, THE PHYSICIAN FOUND THE MID SHAFT OF THE FIRST 4MAXC TO BE OVALIZED AND FLATTENED WHILE UNDER ASPIRATION AND PULLING OUT THE NON-PENUMBRA STENT RETRIEVER. THEREFORE, THE 4MAXC WAS REMOVED. THE PHYSICIAN THEN USED A NEW 4MAXC; BUT, THE SAME ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739796 ↗
• MalfunctionJun 27, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M2 AND M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERS (4MAXC)S. DURING THE PROCEDURE, THE PHYSICIAN FOUND THE MID SHAFT OF THE FIRST 4MAXC TO BE OVALIZED AND FLATTENED WHILE UNDER ASPIRATION AND PULLING OUT THE NON-PENUMBRA STENT RETRIEVER. THEREFORE, THE 4MAXC WAS REMOVED. THE PHYSICIAN THEN USED A NEW 4MAXC; BUT, THE SAME ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739781 ↗
• MalfunctionMar 22, 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 HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED 4MAX WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 4MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6425794 ↗