Penumbra Coil 400 4006U0304-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548019505), received between Apr 20, 2021 and Sep 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THE INITIAL PC400S INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400 INTO THE TARGET VESSEL, THE PUSHER ASSEMBLY OF THE PC400 KINKED AND BROKE. HOWEVER, THE PC400 REMAINED ATTACHED TO ITS PUSHER ASSEMBLY. THE PHYSICIAN THEN DETACHED THE PC400 WITH PART OF THE PC400 IN THE PX SLIM AND THE OTHER PART OF THE PC400 IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN SUCCESSFULLY PUSHED THE REMAINING PART OF THE PC400 INTO THE TARGET VESSEL USING A GUIDEWIRE. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448038 ↗
• MalfunctionApr 20, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM. DURING THE PROCEDURE, A PC400 WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE PC400 WITH THE HEMOSTATS BUT WAS UNSUCCESSFUL. THE PHYSICIAN REMOVED BOTH THE PX SLIM AND PC400, AND THE PC400 CAME OUT OF THE PX SLIM DETACHED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692981 ↗