Penumbra Coil 400 4004C0925Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244004C09250), received between Sep 12, 2015 and Jul 18, 2017 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID AND OPHTHALMIC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, ONE PC400 UNINTENTIONALLY DETACHED WHILE PARTIALLY ADVANCED OUT OF THE TIP OF THE MICROCATHETER AS THE PHYSICIAN ATTEMPTED TO WITHDRAW THE PC400. THE PHYSICIAN WAS ABLE TO PLACE THE DETACHED PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723493 ↗
• 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 6579949 ↗
• InjuryNov 17, 2016Break; Detachment Of Device Component; Break; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, WHILE RETRACTING A PC400 BACK INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN) IN ORDER TO REPOSITION THE COIL, THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE; HOWEVER, THE COIL UNINTENTIONALLY DETACHED. MOST OF THE COIL WAS INSIDE THE PATIENT AND A LITTLE TAIL OF THE COIL REMAINED IN THE LANTERN. THEREFORE, THE PHYSICIAN ACCESSED THE CONTRALATERAL AND USED A SNARE DEVICE TO PULL THE PC400 OUT OF THE LANTERN AND INTO THE OTHER MANUFACTURER¿S CATHETER. WHILE THE PC400 WAS BEING PULLED INTO THE CATHETER, IT BROKE IN HALF. THE PHYSICIAN WAS ABLE TO PULL MOST OF THE COIL THROUGH THE CATHETER BY HAND AND THEN REMOVED THE REST BY PULLING OUT THE CATHETER. THE PROCEDURE ENDED AT THIS POINT. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) BUT DID MAINTAIN 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 6111743 ↗
• MalfunctionJul 20, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A FEW PC400 COILS INTO THE PATIENT USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS ONLY ABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH BUT NOT INTO THE PX SLIM. THEREFORE, THE PC400 COIL WAS REMOVED AND ADDITIONAL PC400 COILS WERE DEPLOYED AND DETACHED INTO THE PATIENT. WHILE ADVANCING ANOTHER NEW PC400 COIL THROUGH THE SAME PX SLIM, THE PHYSICIAN EXPERIENCED FRICTION AND DECIDED TO RETRACT THE COIL. WHILE THE PHYSICIAN WAS RETRACTING THE PC400 COIL, IT BECAME STRETCHED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL PC400 COILS AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND ALSO MAINTAINED A CONTINUOUS FLUSH THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5808590 ↗
• InjurySep 12, 2015Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400) COILS. WHILE ATTEMPTING TO WITHDRAW A PC400 COIL FROM THE PATIENT, IT BECAME STRETCHED AND UNINTENTIONALLY DETACHED. A SNARE DEVICE WAS REQUIRED TO SUCCESSFULLY REMOVE THE PC400 COIL FROM THE PATIENT. THE PROCEDURE CONTINUED USING A NEW PC400 COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5073020 ↗