Penumbra Coil 400 4004C0615-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548018485), received between Apr 8, 2020 and May 7, 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.

• MalfunctionMay 7, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COILS 400 (PC400S), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE TECH EXPERIENCED DIFFICULTY PUSHING THE PC400 IN THE INTRODUCER SHEATH. THE TECH PUSHED HARD, AND THE PUSHER ASSEMBLY OF THE PC400 KINKED. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794813 ↗
• MalfunctionApr 8, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VEIN OF GALEN USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR PC400S IN THE VEIN USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING COIL. THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE AND PLACED ANOTHER PC400 IN THE VEIN. WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM, THE COIL UNINTENTIONALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY WITH PART OF THE COIL STILL ATTACHED. THE REST OF THE COIL THAT REMAINED IN THE PX SLIM WAS PUSHED INTO THE VEIN. THE PROCEDURE WAS COMPLETE WITH OTHER PC400S, NON-PENUMBRA COILS, 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 9941358 ↗