Penumbra Coil 400 4004C0715Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M4244004C07150), received between May 6, 2016 and Jan 29, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2020Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PENUMBRA COIL 400 (PC400) WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE. THE ISSUE WITH THE PC400 WAS FOUND PRIOR TO USE, THEREFORE, THE PC400 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644057 ↗
• MalfunctionApr 3, 2019Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN FELT SLIGHT RESISTANCE AND CONTINUED TO PUSH HARDER. SUBSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED AND THE COIL UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY AND ASPIRATED ON THE PX SLIM AND SAFELY REMOVED THE DETACHED COIL OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW PC400 WITH THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8477959 ↗
• 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 7603833 ↗
• MalfunctionOct 3, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400''S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO PC400S INTO THE TARGET VESSEL USING THE PX SLIM WITH NO ISSUES. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM WITH THE PC400 AND COMPLETED THE PROCEDURE USING A NON-PENUMBRA MICROCATHETER AND PENUMBRA SMART COILS (SMART COILS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909915 ↗
• MalfunctionFeb 2, 2017Detachment Of Device Component; Stretched; Physical Resistance; Detachment Of Device Component; Stretched; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) WITHOUT EXPERIENCING ANY RESISTANCE BUT DECIDED TO RETRACT THE COIL IN ORDER TO REPOSITION IT. WHILE RETRACTING THE PC400, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE. SUBSEQUENTLY, THE PC400 BECAME STRETCHED AND UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PHYSICIAN PUSHED THE PC400 INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY AND THEN COMPLETED THE PROCEDURE USING NEW PENUMBRA SMART COILS, POD COILS AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6297650 ↗
• MalfunctionDec 16, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER AND ATTEMPTED TO REPOSITION IT; HOWEVER, UPON RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN THEN USED A NEW PC400 TO PUSH THE DETACHED PC400 INTO THE TARGET VESSEL WITH NO ISSUES. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME PX SLIM. 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 6183411 ↗
• MalfunctionMay 6, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 UNINTENTIONALLY DETACHED WITH PART OF THE COIL REMAINING INSIDE OF THE PX SLIM AND THE OTHER PART OF THE COIL OUTSIDE OF THE PX SLIM. IN AN ATTEMPT TO PUSH THE DETACHED PC400 OUT OF THE PX SLIM COMPLETELY AND INTO THE TARGET VESSEL, THE PHYSICIAN ADVANCED A NEW PC400 THROUGH THE PX SLIM; HOWEVER, THE NEW PC400 DETACHED AS WELL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE TWO DETACHED PC400 COILS IN THE TARGET VESSEL BY USING A NEW PC400; HOWEVER, THE NEW PC400 DETACHED WHILE BEING ADVANCED THROUGH THE PX SLIM. THE SAME SCENARIO HAPPENED WITH A NEW (FOURTH) PC400. FINALLY, THE PHYSICIAN SUCCESSFULLY PUSHED ALL FOUR DETACHED PC400 COILS OUT OF THE PX SLIM AND INTO THE TARGET VESSEL USING A NEW PC400. THE PROCEDURE WAS COMPLETED USING THAT PC400 AND TWO ADDITIONAL PC400 COILS AND THE SAME PX SLIM USED THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5638113 ↗