Penumbra Coil 400 4004C0610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244004C06100), received between Mar 7, 2018 and Sep 14, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, ONE LOOP OF A PC400 UNEXPECTEDLY EXITED THE TARGET LOCATION AND BECAME LODGED NEAR THE SUPERIOR M2 BRANCH OF THE LEFT MCA WHEN THE PC400 WAS DETACHED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7879408 ↗
• MalfunctionJun 14, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400¿S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PC400. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER PC400'S. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ADDITIONAL PC400¿S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7603747 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Retraction Problem; Separation Failure; Detachment Of Device Component; Retraction Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400¿S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND SLIGHTLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PC400 AND THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ADVANCED A NEW PC400 IN THE TARGET AND ATTEMPTED TO DETACH IT USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE); HOWEVER, THE COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY PULLED THE PULL WIRE BUT THE PC400 WOULD NOT DETACH. THE PHYSICIAN THEN PULLED THE LANTERN BACK A BIT AND MANUALLY PULLED THE PULL WIRE AGAIN; HOWEVER, THE PC400 WOULD STILL NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRACT THE ENTIRE PC400 FROM THE LANTERN; HOWEVER, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE PC400 PUSHER ASSEMBLY, THEN USED ANOTHER PUSHER WIRE TO PUSH THE DETACHED COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, A POD6, OTHER COILS AND GLUE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321942 ↗