Penumbra Coil 400 4004C0815Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244004C08150), received between Dec 31, 2019 and Mar 15, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S USING THE PX SLIM. SUBSEQUENTLY, THE NEXT PC400 UNINTENTIONALLY DETACHED WHILE BEING ADVANCED THROUGH THE PX SLIM TO THE TARGET VESSEL. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT AS NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13774513 ↗
• MalfunctionMar 12, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PC400 PREMATURELY DETACHED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE HAS BEEN PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825970 ↗
• MalfunctionDec 31, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400) AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE DETACHED PC400 AND THEN REMOVED THE PC400. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536329 ↗