Penumbra Coil 400 4002C1857-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548019345), received between Nov 30, 2023 and May 2, 2024 — classified as 2 malfunctions.

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

• MalfunctionMay 2, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 INTO THE CAROTID SINUS AND NOTICED THAT THE PC400 WAS OVERSIZED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE PC400, THE PC400 UNINTENTIONALLY DETACHED, WITH PART OF THE COIL WITHIN THE MICROCATHETER AND THE OTHER PART IN THE MID-AORTA. THE PHYSICIAN THEN USED A SNARE TO RETRIEVE THE DETACHED PC400. THE PROCEDURE WAS COMPLETED USING FIVE 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 19235032 ↗
• MalfunctionNov 30, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, AFTER ADVANCING APPROXIMATELY TWENTY CENTIMETERS OF A PC400 INTO THE FISTULA, THE PHYSICIAN REPORTED THAT THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT. NEXT, THE PHYSICIAN RE-ADVANCED THE SAME PX SLIM INTO THE FISTULA. WHILE ADVANCING ANOTHER PC400 HALFWAY THROUGH THE PX SLIM, THE COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THE PHYSICIAN PREFERRED TO USE A DIFFERENT CATHETER AND DECIDED TO REMOVE THE NEURON 070 FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS, A NON-PENUMBRA CATHETER, THE SAME LONG SHEATH, AND A LIQUID EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241642 ↗