Penumbra Coil 400 4006C0404-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548018201), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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.

• MalfunctionMar 21, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PERICALLOSAL ARTERY ANEURYSM USING A PENUMBRA COIL 400 (PC400), PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NON-PENUMBRA STENT. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE PX SLIM BEHIND THE NON-PENUMBRA STENT AND THEN ADVANCED A PC400 INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN PULLED HARD ON THE PUSHER ASSEMBLY OF THE PC400 AND MADE SEVERAL ATTEMPTS TO DETACH THE PC400 USING THE HANDLE, BUT THE COIL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PC400. SUBSEQUENTLY, WHILE RETRACTING THE PC400 BACK INTO THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN, THEREFORE REMOVED THE PX SLIM CONTAINING THE DETACHED PC400. THE PROCEDURE HAD ENDED AT THIS POINT. THE PHYSICIAN PLANS TO ATTEMPT RE-COIL THE ANEURYSM AT A DIFFERENT DATE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583277 ↗