Penumbra System 5MAXDDC115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548012667), received between Feb 9, 2018 and Feb 9, 2018 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2018Break; Split; Break; Split

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETERS (5MAX DCC'S). DURING THE PROCEDURE, WHILE IN USE WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A 5MAX DCC INTO THE PATIENT; HOWEVER, THE 5MAX DDC SPLIT AND BROKE IN HALF APPROXIMATELY AN INCH FROM THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 5MAX DDC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7261807 ↗