Penumbra System PSC054L125-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548012759), received between Mar 14, 2017 and Apr 10, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT VERTEBRAL ARTERY USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT¿S VERTEBRAL VESSELS WERE ELONGATED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 5MAXC THROUGH THE NEURON MAX. THEN, WHILE ADVANCING THE BALLOON CATHETER APPROXIMATELY 5 CENTIMETERS FROM THE DISTAL END OF THE 5MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE BALLOON CATHETER AND 5MAXC WERE REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE BALLOON CATHETER AND 5MAXC WERE DAMAGED. IT WAS REPORTED THAT 2 TO 5 CENTIMETERS FROM THE DISTAL END OF THE 5MAXC WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING A NEW 5MAXC AND NEW BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948530 ↗
• MalfunctionMar 29, 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 5MAX REPERFUSION CATHETER (5MAX) WAS KINKED AND COMING APART UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGED 5MAX WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6443042 ↗
• InjuryMar 14, 2017Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SECTION OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REMOVE THROMBUS FOR THE FIRST AND SECOND PASS USING A STENT RETRIEVER DEVICE AND A 5MAX; HOWEVER, THE THROMBUS WAS PULLED PROXIMAL AND NO REPERFUSION WAS ACHIEVED. THE STENT RETRIEVER WAS THEN REMOVED, ANOTHER STENT DEVICE WAS ADVANCED WITH THE 5MAX FOR THE THIRD PASS; HOWEVER, NO REPERFUSION WAS ACHIEVED. THEREFORE, THE STENT RETRIEVER AND 5MAX WERE REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE 5MAX WAS BROKEN IN TWO PIECES. THE 5MAX WAS THEN DISCONNECTED FROM THE PUMP MAX AND A NEURON MAX 6F 088 (NEURON MAX) WAS CONNECTED TO THE PUMP MAX; HOWEVER, ONLY SLOW REVERSAL FLOW OCCURRED. UPON CHECKING THE PUMP MAX, THE PHYSICIAN NOTICED THAT NO VACUUM WAS DETECTED. IT WAS ALSO REPORTED THAT THE PUMP MAX INTERMITTENTLY DID NOT PRODUCE ENOUGH VACUUM DURING THE FIRST, SECOND AND THIRD PASS. THE PHYSICIAN THEN PERFORMED MANUAL ASPIRATION WITH A 20ML SYRINGE AND AN ANGIOGRAPHY. ACCORDING TO THE PHYSICIAN, IN CONSEQUEN

  Patient problems: Hemorrhage, Subarachnoid; Neurological Deficit/Dysfunction; Perforation of Vessels

  MAUDE report 6404654 ↗