Penumbra Coil 400 4002C1557Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M4244002C15570), received between Sep 23, 2016 and Feb 14, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A 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 13520970 ↗
• MalfunctionJun 23, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, A PC400 WOULD NOT TAKE ITS INTENDED SHAPE WITHIN THE TARGET VESSEL. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051790 ↗
• MalfunctionJun 3, 2021Component Missing; Component Missing

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 THROUGH A PX SLIM. HOWEVER, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE PC400 DID NOT EXIST THROUGH THE DISTAL TIP OF THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND RE-SHEATHED IT. AFTERWARDS, ON THE BACK TABLE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PC400 BUT ONLY THE PUSHER ASSEMBLY OF THE PC400 WAS FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935420 ↗
• MalfunctionMar 22, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; 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 THE PHYSICIAN ADVANCED A PC400 INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, PART OF THE PC400 BECAME STUCK IN THE MICROCATHETER AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PC400 AND NOTICED UPON REMOVAL THAT THERE WAS A KNOT IN THE MIDDLE OF THE PC400. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S 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 11547807 ↗
• MalfunctionOct 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM AND INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK IN THE PX SLIM. THEREFORE, PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PX SLIM AND ADDITIONAL PC400S. 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 10758220 ↗
• MalfunctionJan 11, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A PC400 THROUGH THE PX SLIM AND, CONSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN THEN TESTED THE PX SLIM BY ADVANCING A GUIDEWIRE THROUGH IT AND CONFIRMED THAT IT WAS OBSTRUCTED. THE PX SLIM WAS THEREFORE REMOVED WITH THE PC400 INSIDE, AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242636 ↗
• MalfunctionJul 26, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A PC400 INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A NEW PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE COIL WAS AT THE TIP OF ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PC400 BECAME STUCK AND WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 6745648 ↗
• 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 5975357 ↗