Penumbra Coil 400 4004C1545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M4244004C15450), received between Aug 29, 2016 and Aug 29, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionAug 29, 2016Detachment Of Device Component; Out-Of-Box Failure; Material Protrusion/Extrusion; Detachment Of Device Component; Out-Of-Box Failure; Material Protrusion/Extrusion

  PRIOR TO USING AND INSERTING THE THIRD PENUMBRA COIL 400 (PC400) INTO THE MICROCATHETER FOR A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY, THE PHYSICIAN NOTICED THAT THE COIL WAS OUTSIDE OF ITS INTRODUCER SHEATH. UPON RESHEATHING THE PC400, THE PHYSICIAN NOTICED THAT IT HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PC400 WAS NOT USED FOR THE PROCEDURE AND WAS NOT INSERTED INTO THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING TWO NEW PC400''S.

  Patient problems: No Patient Involvement

  MAUDE report 5912624 ↗