Penumbra Coil 400 4002C0935Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M4244002C09350), received between Sep 23, 2016 and Jan 7, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON DELIVERY CATHETER 070 (NEURON 070), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE NEURON MAX INTO THE PATIENT THEN ADVANCED THE NEURON 070 AND THE PX SLIM THROUGH THE NEURON MAX. NEXT THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN PC400S IN THE TARGET VESSEL. WHILE ADVANCING THE EIGHTH PC400 THROUGH THE PX SLIM THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192770 ↗
• MalfunctionMay 14, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DETACH A PC400 USING THE HANDLE, THE COIL ALIGNMENT ZONE SEPARATED BUT THE COIL DID NOT DETACH. IT WAS REPORTED THAT THE CLICK OF THE HANDLE WAS NOT AUDIBLE. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO DETACH THE PC400 USING THE HANDLE; HOWEVER, THE PUSHER ASSEMBLY OF THE PC400 BECAME STUCK IN THE HANDLE. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PC400. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED ANOTHER PC400 IN THE TARGET VESSEL USING ANOTHER HANDLE. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT PC400 THROUGH THE MICROCATHETER, THE PC400 UNINTENTIONALLY DETACHED AND BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT. 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 11828688 ↗
• MalfunctionApr 14, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OFF THE POSTERIOR COMMUNICATING ARTERY (PCA) USING PENUMBRA COILS 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIVE PC400S VIA THE PX SLIM. WHILE ADVANCING AND ADJUSTING THE SIXTH PC400 IN AND OUT OF THE ANEURYSM TO OBTAIN A BETTER POSITION, THE PHYSICIAN FELT THE PC400 BREAK. THE PHYSICIAN ATTEMPTED TO REMOVE THE PC400, BUT IT WAS PARTIALLY BROKEN. THEREFORE, THE BROKEN PIECE OF PC400 WAS REMOVED TOGETHER WITH THE PX SLIM AND BENCHMARK. THE EMBOLIZATION WAS COMPLETED, AND THE PROCEDURE CONCLUDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668374 ↗
• MalfunctionMar 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT COMMON CAROTID ARTERY USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO PC400S INTO THE TARGET LOCATION USING THE PX SLIM. THEN, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEXT PC400 OUT OF ITS INTRODUCER SHEATH INTO THE RHV OF THE PX SLIM, THE PC400 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE PC400 WAS REMOVED. 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 11495357 ↗
• MalfunctionDec 16, 2020Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIVE COILS IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN FOUND THE PUSHER ASSEMBLY OF A PC400 WAS DAMAGED WHILE REMOVING IT FROM THE DISPENSER HOOP. THE PHYSICIAN THEN INSERTED THE INTRODUCER SHEATH INTO HUB OF THE MICROCATHETER AND ATTEMPTED TO PUSH THE PUSHER ASSEMBLY OF THE PC400 INTO THE ROTATING HEMOSTASIS VALVE (RHV); HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE PUSHER ASSEMBLY OF THE PC400 BROKE IN TWO PIECES. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400. 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 11015800 ↗
• MalfunctionDec 27, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE THE FIRST COIL, A PC400, THROUGH ITS INTRODUCER SHEATH AND WAS UNABLE TO ADVANCE THE PC400 BEYOND ITS STARTING POSITION. THE PC400 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 AND THE SAME PX SLIM DELIVERY MICROCATHETER (PX SLIM). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199341 ↗
• MalfunctionFeb 6, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PENUMBRA COIL 400'S (PC400S). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN TOWARDS THE TARGET PORTION OF THE PORTAL VEIN, THEN DEPLOYED AND DETACHED AN INITIAL POD5. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND THE MIDDLE OF THE LANTERN AND DECIDED TO REMOVE THE WHOLE SYSTEM FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PC400 THROUGH THE LANTERN OUTSIDE THE PATIENT'S BODY; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THEREFORE, THE LANTERN AND PC400 WERE SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246375 ↗
• MalfunctionMar 10, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA COILS 400 (PC400¿S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INITIAL PC400S THROUGH A PX SLIM WITHOUT A ROTATING HEMOSTASIS VALVE (RHV) AND CONTINUOUS FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND PC400S WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE NEW PC400S; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400S WOULD NOT ADVANCE THROUGH THE NEW PX SLIM. THEREFORE, THE PC400S WERE REMOVED. IT WAS REPORTED THAT AFTER CONNECTING THE PX SLIM WITH A RHV, A FLUSH LINE AND HOLDING THE HUB OF THE PX SLIM STRAIGHT, THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND 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 6395030 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE LEFT PARAOPHTHALAMIC ARTERY USING PENUMBRA COIL 400 (PC400'S) WITH NO COMPLICATIONS DURING THE PROCEDURE. HOWEVER, SIX HOURS POST-PROCEDURE, THE PATIENT DEVELOPED APHASIA, WHICH PROGRESSED TO RIGHT-SIDED WEAKNESS. A FOLLOW-UP ANGIOGRAPHY WAS PERFORMED AND SHOWED DECREASE BLOOD FLOW INTO THE MIDDLE CEREBRAL ARTERY (MCA) AND A THROMBUS IN THE M3 BRANCH OF THE LEFT INTERNAL CAROTID ARTERY (LICA) WAS NOTICED. THEREFORE, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE, WHICH PARTIALLY REMOVED THE THROMBUS; HOWEVER, A FRAGMENT OF THE THROMBUS WENT DOWNSTREAM AND COULD NOT BE REMOVED. THE PATIENT WAS STILL ADMITTED IN THE HOSPITAL. AS OF (B)(6) 2016, THE PATIENT WAS IN STABLE CONDITION. THIS SERIOUS ADVERSE EVENT WAS REPORTED AS AN ISCHEMIC STROKE AND WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE PC400'S, THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM MALFORMATION.

  Patient problems: Dysphasia; Thrombus; Weakness

  MAUDE report 5975430 ↗