Penumbra System PSC054KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548016771), received between Jun 26, 2020 and Jun 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE WHILE ADVANCING THE 5MAXC THROUGH THE NEURON MAX AND WHILE ADVANCING THE 3MAXC THROUGH THE 5MAXC. AFTER ADVANCING THE 3MAXC INTO THE DISTAL BRANCH OF THE TARGET VESSEL, A PASS WAS COMPLETED USING A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT). WITH THE CLOT ON THE TIP OF THE 3MAXC AND UNDER ASPIRATION, THE PHYSICIAN RETRACTED THE 3MAXC INTO THE 5MAXC WITH NO SIGNIFICANT RESISTANCE. HOWEVER, IT SEEMED LIKE A SECTION OF THE 3MAXC BROKE OFF. AFTER REMOVING THE 5MAXC, IT WAS NOTICED THAT APPROXIMATELY FIVE TO TEN CENTIMETERS OF THE DISTAL END OF THE 3MAXC WAS FOUND INSIDE THE 5MAXC, ALONG WITH THE THROMBUS. THE PROCEDURE WAS ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201401 ↗