Penumbra Coil 400 4004C0820-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548018539), received between Dec 12, 2019 and Mar 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMar 12, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A PENUMBRA COIL 400 (PC400), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE PC400 NINE TIMES USING THE HANDLE, BUT THE PC400 WOULD NOT DETACH. IT WAS REPORTED THAT THE PC400 PUSHER ASSEMBLY DETACHMENT ZONE WAS STUCK IN THE HANDLE AND COULD NOT BE REMOVED. THE PHYSICIAN THEN PULLED THE PC400 PUSHER ASSEMBLY DETACHMENT ZONE WITH THE HANDLE ATTACHED TO MANUALLY DETACH THE PC400 WITHOUT SUCCESS. THE PC400 WAS THEN ADVANCED AND RETRACTED WITHIN THE ACCESS25, BUT THE PC400 WOULD NOT DETACH. THE PHYSICIAN ADVANCED AND RETRACTED THE ACCESS25 TO REPOSITION, BUT THE PC400 WOULD NOT DETACH. AFTER MULTIPLE ATTEMPTS TO DETACH THE PC400, THE PHYSICIAN DECIDED TO REMOVE THE PC400. WHILE RETRACTING THE PC400, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE ACCESS25. THE PHYSICIAN THEN USED THE PC400 PUSHER ASSEMBLY TO GENTLY PUSH THE DETACHED PC400 INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL PC400S, ANOTHER HANDLE, AND THE SAME ACCESS25. THERE WAS NO RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590417 ↗
• MalfunctionDec 12, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED A PC400 INTO THE TARGET VESSEL AND REPORTED THAT IT WAS TOO LARGE. BEFORE THE PC400 COULD BE REMOVED, IT "KNOTTED" ON ITSELF WITHIN THE ANEURYSM. THEREFORE THE PC400 WAS REMOVED. IT WAS ALSO REPORTED THAT A HANDLE WAS DROPPED ONTO THE TABLE AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX, THE SAME PX SLIM, AND ANOTHER PC400 WHICH WAS MANUALLY DETACHED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460585 ↗