Penumbra Coil 400 4002C0610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244002C06100), received between Jul 19, 2016 and Sep 5, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2018Difficult or Delayed Activation; Premature Separation; Difficult or Delayed Activation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND USED A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) TO DETACH THE PC400. ALTHOUGH THE DETACHMENT ZONE WAS CUT OFF, THE PHYSICIAN PULLED THE PC400 PUSHER ASSEMBLY AND OBSERVED THAT THE PC400 WAS STILL ATTACHED TO ITS PUSHER ASSEMBLY; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PC400. HOWEVER, WHILE WITHDRAWING THE PC400 AND THE PX SLIM TOGETHER, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE NON-PENUMBRA GUIDING CATHETER. THE PHYSICIAN THEN WITHDREW THE PC400 AND THE GUIDING CATHETER TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW PC400, THE SAME HANDLE, PX SLIM AND GUIDING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847679 ↗
• MalfunctionOct 19, 2016Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance

  WHILE PREPARING A PENUMBRA COIL 400 (PC400) FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE BUT THE COIL WAS UNABLE TO ADVANCE OUT. THEREFORE, THE PC400 COIL WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Patient Involvement

  MAUDE report 6042376 ↗
• 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 5804178 ↗