Penumbra Coil 400 4006C0202-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548018126), received between May 4, 2021 and May 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionMay 4, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN PC400S INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ATTEMPTING TO ADVANCE THE EIGHTH PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE INTRODUCER SHEATH OF THE PC400 AND CONSEQUENTLY, THE PC400 WOULD NOT ADVANCE INTO THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769996 ↗