Penumbra Coil 400 4002C1145Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244002C11450), received between Mar 14, 2016 and Sep 2, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS INTO THE FIRST ANEURYSM USING THE PX SLIM. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE PC400 INTO THE SECOND ANEURYSM USING THE PX SLIM. SUBSEQUENTLY, WHILE ADVANCING A SECOND PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 15351078 ↗
• MalfunctionNov 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 INTO THE PX SLIM, THE PC400 BECAME STUCK. THEREFORE, THE PC400 WAS REMOVED. NEXT, WHILE ADVANCING A NEW PC400 INTO THE PX SLIM, THE SAME ISSUE OCCURRED, THE PC400 BECAME STUCK. THEREFORE, THE PC400 AND THE PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741064 ↗
• MalfunctionApr 16, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT INTERNAL CAROTID ARTERY (ICA) CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COILS 400 (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA GUIDING CATHETER). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET LOCATION WITH A GUIDE CATHETER. NEXT, THE PHYSICIAN PLACED FOUR PC400S INTO THE TARGET LOCATION USING THE PX SLIM. THEN, WHILE ADVANCING THE FIFTH PC400 MIDWAY THROUGH THE MICROCATHETER, THE PC400 BECAME STUCK. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED, WITH THE DISTAL END OF THE PC400 ENTANGLED IN THE COIL MASS AND THE PROXIMAL END OF THE PC400 DETACHED WITHIN THE PX SLIM. TO PREVENT DISTURBING THE COIL MASS, THE PHYSICIAN DECIDED TO LEAVE THE FIFTH PC400 IN THE ICA. AFTERWARDS, A VESSEL SACRIFICE WAS PLANNED AND SINCE THE CROSSFLOW FROM THE LEFT ICA HAD GOOD FLOW, ANOTHER PC400 WAS PLACED IN THE ICA. SUBSEQUENTLY, THE VESSEL WAS SACRIFICED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER PC400 TO PACK THE ICA TIGHTLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681510 ↗
• MalfunctionFeb 5, 2020Difficult to Advance; Physical Resistance/Sticking; Premature Separation; Difficult to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY TO RETREAT AN ANEURYSM USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT IN A PRIOR TREATMENT, PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA COILS WERE PLACED IN THE PATIENT'S TARGET VESSEL. DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM IN THE VESSEL, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE BUT WAS ABLE TO ADVANCE IT FURTHER. THE PC400 THEN CAME OUT OF THE PX SLIM AND UNINTENTIONALLY DETACHED IN THE VESSEL; SUBSEQUENTLY, THE PHYSICIAN PUSHED THE PC400 INTO THE ANEURYSM AND PLACED IT. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9674241 ↗
• MalfunctionMar 14, 2016Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED AN INITIAL PC400 COIL INTO THE ANEURYSM. WHILE PREPARING A NEW PC400 COIL FOR THE PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE BATH BEFORE INTRODUCING IT INTO THE PATIENT. THEREFORE, THE SECOND PC400 COIL WAS NOT USED FOR THE PROCEDURE AND DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING NEW PC400 COILS.

  Patient problems: No Patient Involvement

  MAUDE report 5498856 ↗