Penumbra System 5MAXDDC125Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548012674), received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJun 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA 5MAX DDC DISTAL DELIVERY CATHER (5MAX DDC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA EMBOLIZATION DEVICE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX, THEN ADVANCED THE 5MAX DDC AND MICROCATHETER THROUGH THE NEURON MAX. WHILE ADVANCING THE EMBOLIZATION DEVICE THROUGH THE MICROCATHETER, THE PUSHER WIRE OF THE EMBOLIZATION DEVICE BECAME STUCK INSIDE THE MICROCATHETER. THE PHYSICIAN BELIEVED THAT THE ROTATING HEMOSTASIS VALVE (RHV) THAT WAS ATTACHED TO THE NEURON MAX WAS TIGHTLY CONNECTED TO THE 5MAX DDC, CAUSING IT TO CLAMP DOWN ON THE MICROCATHETER AND THE EMBOLIZATION DEVICE. THEREFORE, THE PHYSICIAN REMOVED THE 5MAX DCC, MICROCATHETER AND EMBOLIZATION DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX DCC, A NEW MICROCATHETER, A NEW EMBOLIZATION DEVICE, 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 10141569 ↗