Penumbra Coil 400 4002C2457Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M4244002C24570), received between Feb 12, 2016 and May 23, 2022 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PORTOSYSTEMIC SHUNT OCCLUSION USING PENUMBRA COIL 400S (PC400), A NON-PENUMBRA SHEATH, NON-PENUMBRA MICROCATHETERS, AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO MICROCATHETERS OVER SEPARATE GUIDEWIRES AND THROUGH THE SHEATH INTO THE TARGET VESSEL AND SUCCESSFULLY IMPLANTED A PC400. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEXT PC400 INTO THE TARGET VESSEL; HOWEVER, THE PC400 UNINTENTIONALLY DETACHED WITH PART OF THE COIL IN THE TARGET VESSEL AND THE OTHER PART IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PC400 PUSHER ASSEMBLY AND USED THE GUIDEWIRE TO PUSH THE PC400 INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING AN EMBOLIC AGENT, A NON-PENUMBRA VASCULAR PLUG, THE SAME NON-PENUMBRA SHEATH, AND THE SAME NON-PENUMBRA MICROCATHTERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478546 ↗
• MalfunctionFeb 14, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400S (PC400S), A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S USING THE NEURON 070 AND PX SLIM. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE THIRD PC400 THROUGH THE PX SLIM. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITH PART OF THE PC400 IN THE PX SLIM AND THE OTHER PART IN THE FISTULA. THEREFORE, THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE PC400 INTO THE FISTULA. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A NEW PC400 THROUGH THE PX SLIM. THE PHYSICIAN DECIDED TO RETRACT THE PC400; HOWEVER, WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED WITH THE DETACHED PC400 INSIDE. THE PROCEDURE WAS 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 13520948 ↗
• MalfunctionFeb 25, 2021Stretched; Premature Separation; Stretched; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COILS 400 (PC400S), A REUSED PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A PC400 (32MM X 60CM) THROUGH A REUSED PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE DETACHED PC400 WAS REMOVED USING A BALLOON CATHETER AND THE PHYSICIAN ALSO REMOVED THE PX SLIM. NEXT, THE PHYSICIAN PLACED ANOTHER PC400 IN THE TARGET LOCATION SUCCESSFULLY USING A NEW PX SLIM. NEXT, WHILE ADVANCING ANOTHER PC400 (28MM X 60CM) TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITH HALF OF THE PC400 IN THE TARGET LOCATION AND THE OTHER HALF OF THE PC400 IN THE PX SLIM. THE PHYSICIAN WAS UNABLE TO REMOVE THE DETACHED PC400 DUE TO THE PC400 BEING TANGLED WITH THE PREVIOUS PLACED PC400. THEREFORE, THE DETACHED PC400 WAS LEFT IN THE PATIENT¿S VESSEL. AFTERWARDS, WHILE ADVANCING ANOTHER PC400 (24MM X 57CM) TO THE TARGET LOCATION, THE PC400 STRETCHED. SUBSEQUENTLY, THE PC4

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

  MAUDE report 11377658 ↗
• MalfunctionFeb 7, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE MICROCATHETER THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PC400. HOWEVER UPON RETRACTION, THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PC400 AND THEN REMOVED THE PC400. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER PC400; HOWEVER, THE SAME ISSUE OCCURRED, AND THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC 400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682931 ↗
• MalfunctionJan 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 BECAME STUCK. THEREFORE, THE PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262029 ↗
• MalfunctionDec 26, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 THROUGH THE HUB OF A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196934 ↗
• MalfunctionMay 7, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE LANTERN IN THE TARGET LOCATION AND THEN ATTEMPTED TO ADVANCE A PC400 THROUGH IT. THE PHYSICIAN, HOWEVER; EXPERIENCED RESISTANCE AROUND THE TIP OF THE COIL REACHING THE TIP OF THE LANTERN AND WAS UNABLE TO ADVANCE THE PC400 THROUGH THE LANTERN, AND THEREFORE THE LANTERN WAS REMOVED WITH THE PC400 INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER, THE SAME PC400, ADDITIONAL 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 7492267 ↗
• MalfunctionJan 31, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FOUR PC400S USING A NON-PENUMBRA MICROCATHETER. THE DISTAL TIP OF A FIFTH PC400 THEN BEGAN TO TAKE ITS SHAPE WHILE THE PC400 WAS PARTIALLY IN THE MICROCATHETER AND PARTIALLY WITHIN THE VESSEL OUTSIDE OF THE ANEURYSM, AND THEREFORE THE PHYSICIAN ATTEMPTING TO PULL AND PUSH THE PUSHER WIRE. CONSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE PLACED THE PARENT CATHETER INTO THE TARGET ANEURYSM AND ADVANCED THE PC400 USING THE PUSHER WIRE, SUCCESSFULLY PLACING THE PC400 IN THE TARGET LOCATION. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER, ANOTHER PC400, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232719 ↗
• MalfunctionJan 16, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 OUT OF ITS INTRODUCER SHEATH AND INTO A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PC400 WAS STUCK AT THE TIP OF ITS INTRODUCER SHEATH. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PC400S AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7198318 ↗
• MalfunctionDec 11, 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 MILDLY TORTUOUS, BUT NO CALCIFICATION, STENOSIS OR CONSTRICTION WAS OBSERVED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA DIAGNOSTIC CATHETER TOWARDS THE TARGET VESSEL THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH THE DIAGNOSTIC CATHETER. WHILE ATTEMPTING TO ADVANCE THE FIRST PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE LANTERN AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE PC400 WAS REMOVED FROM THE LANTERN AND A NEW PC400 WAS OPENED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH THIS SUBSEQUENT PC400 AND THEREFORE, THE COIL WAS REMOVED FROM THE LANTERN. AFTER THAT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A NEW PC400 INTO THE TARGET VESSEL USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE LANTERN AGAIN AND THEREFORE, THE PC400 WAS REMOVED. THE LANTERN WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106620 ↗
• MalfunctionJul 22, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY FIVE TO TEN CENTIMETERS FROM THE TIP OF THE MICROCATHETER. THEREFORE, THE PC400 COIL WAS REMOVED AND THE PHYSICIAN CONTINUED THE PROCEDURE BY DEPLOYING AND DETACHING SEVEN NEW PC400 COILS INTO THE TARGET VESSEL USING THE SAME MICROCATHETER AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). WHILE ATTEMPTING TO DETACH THE EIGHTH PC400 COIL IN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED DIFFICULTY AND WAS UNABLE TO DETACH THE PC400 COIL AFTER A SECOND ATTEMPT. THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE TO DETACH THE EIGHTH PC400 COIL AND THE PROCEDURE WAS COMPLETED AT THIS POINT. IT SHOULD BE NOTED THAT THE PATIENT HAD SLIGHTLY TORTUOUS ANATOMY AROUND THE CELIAC ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5817717 ↗
• MalfunctionFeb 12, 2016Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE DETACHING FOUR PC400 COILS IN THE ANEURYSM USING THE HANDLE, THE PHYSICIAN EXPERIENCED SMOOTH AND ROUGH DETACHMENTS OF THE COILS, WHICH REQUIRED MULTIPLE ATTEMPTS. THE PHYSICIAN THEN MADE THREE ATTEMPTS TO DETACH A FIFTH PC400 COIL USING THE HANDLE; HOWEVER, THE COIL WAS UNABLE TO DETACH SO THE PHYSICIAN BENT THE MARKER ALIGNMENT ZONE OF THE PC400 COIL PUSHER ASSEMBLY AND MANUALLY PULLED ON THE PUSHER ASSEMBLY BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING SIX NEW PC400 COILS AND ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5435707 ↗