Penumbra Coil 400 4002C0925Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M4244002C09250), received between Oct 21, 2016 and May 23, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PORTAL ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A PC400 INTO THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED ANOTHER PC400 INTO THE TARGET LOCATION; HOWEVER, WHILE ATTEMPTING TO REPOSITION THE PC400, THE COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN REMOVED THE DETACHED PC400 USING A STENT RETRIEVER. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400, A PAC400, 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 19386624 ↗
• MalfunctionJan 30, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400S (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH THE PX SLIM AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PC400; THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED AS WELL. THE PROCEDURE WAS COMPLETED USING A NEW PC400 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 16264085 ↗
• MalfunctionJun 18, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERICALLOSAL ARTERY USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE PC400 IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE, BUT REPORTED THAT THE PC400 WOULD NOT DETACH AFTER SEVERAL ATTEMPTS. THE PC400 AND THE HANDLE WERE THEREFORE REMOVED AND WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND ANOTHER HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709522 ↗
• MalfunctionOct 29, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, AFTER DEPLOYING A PC400 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN ADVANCED AND RETRACTED THE PC400 SEVERAL TIMES FOR REPOSITIONING; HOWEVER, WHEN RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN WITHDREW THE LANTERN CONTAINING THE DETACHED PC400 AND FLUSHED THE COIL OUT. THE PROCEDURE WAS COMPLETED USING THREE OTHER PC400S AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8014963 ↗
• 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 7603552 ↗
• MalfunctionOct 21, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND THE PC400 BECAME STUCK. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM FROM THE PATIENT AND SUCCESSFULLY REMOVED THE PC400 FROM IT. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND NEW PC400S. THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE AND MAINTAINING CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6047676 ↗