Penumbra Coil 400 4004C1335-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548019024), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (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 18, 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 12, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A PENUMBRA COIL 400 (PC400) AND A MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE PC400 INTO THE ANEURYSM USING THE MICROCATHETER, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WITH THE MAJORITY IF THE PC400 INSIDE THE ANEURYSM. THEREFORE, THE PUSHER ASSEMBLY OF THE PC400 WAS USED TO SUCCESSFULLY PUSH THE REMAINING PC400 INTO THE ANEURYSM. THE PROCEDURE 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 9702413 ↗