Penumbra Coil 400 4004C0720Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M4244004C07200), received between Sep 30, 2015 and Jan 30, 2023 — classified as 1 death, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PC400; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED AS WELL. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264076 ↗
• MalfunctionJun 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COILS 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S. WHILE ATTEMPTING TO ADVANCE THE THIRD PC400, THE PHYSICIAN EXPERIENCED RESISTANCE, THE COIL GOT STUCK AND WOULD NOT EXIT THE DISTAL TIP OF THE MICROCATHETER. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916642 ↗
• MalfunctionJan 7, 2021Physical 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 COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 OUT OF THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE FURTHER. THE PHYSICIAN THEN ATTEMPTED TO PULL THE PC400 IN THE PX SLIM AND EXPERIENCED RESISTANCE AGAIN. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE DETACHED PC400 AND PX SLIM WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11129417 ↗
• MalfunctionAug 21, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PENUMBRA COIL 400 (PC400) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PC400 IN THE DISTAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 WOULD NOT ADVANCE OUT OF THE MICROCATHETER. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10436791 ↗
• MalfunctionJun 22, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE PC400S AND OTHER COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE PC400. WHILE RETRACTING, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER WITH THE PC400 INSIDE. AFTER REMOVAL, THE PHYSICIAN PUSHED THE EMBOLIZATION COIL OUT OF THE MICROCATHETER TO CONFIRM THAT IT WAS NOT IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, NEW PC400S, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631719 ↗
• MalfunctionDec 21, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400'S (PC400'S). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA GUIDE CATHETER TOWARDS THE RIGHT IIA, THEN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH IT AND PLACED FOUR INITIAL PC400'S. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL MIDWAY THROUGH THE MICROCATHETER AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE MICROCATHETER CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME GUIDE CATHETER AND THREE ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139833 ↗
• MalfunctionMay 19, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S). IT WAS NOTED THAT THE PATIENT HAD A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 (F65128) INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ATTEMPTED TO DETACH THE PC400 USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE); HOWEVER, THE PC400 FAILED TO DETACH. IT WAS NOTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE PUSHER ASSEMBLY ONLY SHOWED A SMALL GAP OF 0.5 CM. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE PX SLIM; HOWEVER, IT DID NOT IMPROVE THE SITUATION; THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400. UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM AND THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED PC400 INTO THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED THE SECOND PC400 (F67056) INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN ENCOUNTERED THE SAME DIFFICULTY WHILE ATTEMPTING TO DETACH THE PC400 USING THE SAME HANDLE. REPOSITIONING THE PX SLIM DID NOT HELP. THE PC400 WAS THEN MANUALLY DETACHED IN THE ANEURYSM. IT WAS REPORTED THAT WHEN MANUALLY DETACHING THIS PC400, RESISTANCE WAS E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6578386 ↗
• MalfunctionSep 16, 2016Detachment Of Device Component; Retraction Problem; Failure to Advance; Detachment Of Device Component; Retraction Problem; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE OPHTHALMIC ARTERY USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIFTEEN PC400'S INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AFTER DEPLOYING A NEW PC400 ABOUT HALF WAY INTO THE ANEURYSM USING THE PX SLIM, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT ADVANCING OR RETRACTING WHEN PUSHING AND PULLING ON THE PUSHER ASSEMBLY. THE PHYSICIAN THEN REALIZED THAT THE PC400 HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PX SLIM WAS REMOVED WITH THE PC400 INSIDE. THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE WHILE ADVANCING OR RETRACTING THE PC400. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S MICROCATHETER AND COILS. IT SHOULD BE NOTED THAT THE PHYSICIAN MAINTAINED A CONTINUOUS FLUSH AND USED A ROTATING HEMOSTASIS VALVE (RHV) THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5958029 ↗
• MalfunctionFeb 10, 2016Detachment Of Device Component; Retraction Problem; Unraveled Material; Physical Resistance; Detachment Of Device Component; Retraction Problem; Unraveled Material; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S CATHETER AND THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE CELIAC ARTERY AND THEN ADVANCED A PC400 COIL THROUGH THE PX SLIM AND INTO THE TARGET VESSEL; HOWEVER, THE PC400 COIL DID NOT COIL PROPERLY BECAUSE ITS SIZE WAS LARGER THAN THE ANEURYSM. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO PROPERLY SETTLE THE PC400 COIL IN THE ANEURYSM, THE PHYSICIAN DECIDED TO WITHDRAW THE COIL. WHILE THE PC400 COIL WAS BEING RETRACTED BACK INTO THE PX SLIM, IT BECAME STUCK AND WAS UNABLE TO BE RETRACTED AFTER APPROXIMATELY 5-6CM. THE PHYSICIAN FORCEFULLY PULLED ON THE PC400 COIL PUSHER ASSEMBLY AND THE PC400 COIL UNINTENTIONALLY DETACHED AND STARTED TO UNRAVEL INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE OTHER MANUFACTURER'S CATHETER CONTAINING THE PX SLIM AND THE PC400 COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMALLER-SIZED PC400 COIL, THE SAME PX SLIM AND THE SAME CATHETER FROM THE OTHER MANUFACTURER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5427281 ↗
• DeathDec 1, 2015Device Operates Differently Than Expected

  THE PATIENT SUCCESSFULLY UNDERWENT A COIL EMBOLIZATION PROCEDURE FOR A RUPTURED SACCULAR ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA) USING FOUR PENUMBRA COILS 400 (PC400 COILS). A THREE MONTHS POST-PROCEDURE FOLLOW UP VISIT CONFIRMED RECANALIZATION OF THE ANEURYSM. A SIX MONTH POST-PROCEDURE FOLLOW-UP VISIT CONFIRMED THE NEED FOR RE-TREATMENT OF THE ANEURYSM. HOWEVER, THREE DAYS PRIOR TO THE SCHEDULED RE-TREATMENT SURGERY, THE ANEURYSM RE-BLED AND THE PATIENT EXPIRED. THE SERIOUS ADVERSE EFFECT:DEATH, WAS ADJUDICATED TO HAVE A POSSIBLE RELATIONSHIP TO THE PC400 SYSTEM, AN UNRELATED RELATIONSHIP TO ANGIOGRAPHIC PROCEDURE, AND A DEFINITE RELATIONSHIP TO ANEURYSM DISEASE STATE.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 5257573 ↗
• InjurySep 30, 2015Insufficient Device Problem Information

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR CEREBRAL ARTERY (ACA)-ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THIRTEEN PC400 COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED INTO THE ANEURYSM WITH NO COMPLICATIONS. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A SEVERE ISCHEMIC STROKE IN THE LEFT ANTERIOR CEREBRAL ARTERY. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), MAGNETIC RESONANCE IMAGING (MRI), ELECTROENCEPHALOGRAM (EEG), TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE PERFORMED AND THE PATIENT WAS TREATED WITH SIMVASTATIN. THE REPORTED ISCHEMIC STROKE RESOLVED ON (B)(6) 2013.

  Patient problems: Stroke/CVA

  MAUDE report 5114178 ↗