Penumbra Coil 400 4006C0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M4244006C04060), received between May 18, 2016 and Feb 6, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A NEURON DELIVERY CATHETER 070 (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON 070 THROUGH THE NEURON MAX TO THE TARGET VESSEL AND THEN ADVANCED THE PX SLIM THROUGH THE NEURON 070 TO THE TARGET VESSEL. NEXT, WHILE ADVANCING A PC400 INTO THE TARGET VESSEL USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE PC400 UNINTENTIONALLY DETACHED AND MIGRATED INTO THE MIDDLE CEREBRAL ARTERY (MCA). THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED PC400. AFTERWARDS, WHILE ADVANCING A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE PC400 UNINTENTIONALLY DETACHED WITH APPROXIMATELY HALF OF THE PC400 IN THE PX SLIM AND THE OTHER HALF IN THE TARGET VESSEL. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS, ANOTHER MICROCATHETER, THE SAME NEURON MAX, AND THE SAME NEURON 070. THERE WAS NO REPORT OF AN ADVERSE EFFECT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467931 ↗
• 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 A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400. HOWEVER, DURING RETRACTION, THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. 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 11134467 ↗
• MalfunctionDec 28, 2017Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INFERIOR GLUTEAL ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SECOND PC400 MORE THAN HALFWAY THROUGH THE PX SLIM. THE PHYSICIAN THEREFORE REMOVED AND ATTEMPTED TO RE-SHEATHE THE PC400, HOWEVER WAS UNABLE TO RETRACT IT INTO THE INTRODUCER SHEATH. THE PROCEDURE WAS THEN COMPLETED USING THE SAME PX SLIM, 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 7151162 ↗
• InjuryJul 19, 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 CHOROIDAL SEGMENT OF THE RIGHT SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. HOWEVER, THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED TWO EPISODES OF TRANSIENT LEFT-SIDED WEAKNESS. ON (B)(6) 2016, A FOLLOW-UP MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED SMALL INFARCTS SCATTERED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY, WHICH RESOLVED ON THE SAME DAY. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY IN STABLE CONDITION. THE SMALL INFARCTS WERE REPORTED TO BE A TRANSIENT ISCHEMIC ATTACK (TIA) AND A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PC400 COILS, THE ANEURYSM AS WELL AS THE ANGIOGRAPHIC PROCEDURE.

  Patient problems: Transient Ischemic Attack; Weakness

  MAUDE report 5804446 ↗
• InjuryJun 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, AFTER DELIVERING FOUR PC400 COILS IN THE TARGET VESSEL, IT WAS NOTICED THAT A PC400 LOOP WAS PROLAPSING IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). NO FLOW OR THROMBOEMBOLIC PROBLEMS WERE OBSERVED; HOWEVER, THE PROTRUDING PC400 LOOP WAS SECURED USING A STENT AND DUAL ANTIPLATELET THERAPY (DAPT). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5763024 ↗
• InjuryMay 18, 2016Entrapment of Device; Migration or Expulsion of Device; Unraveled Material; Entrapment of Device; Migration or Expulsion of Device; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAJOR AORTO-PULMONARY COLLATERAL ARTERY (MAPCA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED EIGHT PC400 COILS INTO THE ANEURYSM. UPON REMOVING THE MICROCATHETER FROM THE PARENT CATHETER, THE ANGIOGRAM REVEALED THAT THE LAST PC400 COIL WAS PUSHED OUT FROM THE COLLATERAL CIRCULATION AND INTO THE PARENT VESSEL BY BLOOD FLOW. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PC400 COIL USING A SNARE DEVICE; HOWEVER, THE PC400 COIL BECAME UNRAVELED. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO RETRIEVE THE UNRAVELED COIL FILAMENTS FROM THE PATIENT'S BODY USING THE SNARE DEVICE; HOWEVER, ON THE THIRD ATTEMPT, THE PC400 COIL FILAMENTS WERE UNINTENTIONALLY CUT OFF. THE REMAINING PORTION OF THE COIL FILAMENTS WERE LEFT IN THE BODY BUT NOT VISIBLE UNDER FLUOROSCOPY. TAKING INTO CONSIDERATION HOW MUCH TIME HAD PASSED, THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 5664050 ↗