Penumbra Coil 400 4006U0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244006U04080), received between Sep 30, 2015 and Feb 5, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Kinked” (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.

• MalfunctionFeb 5, 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 13467141 ↗
• MalfunctionApr 18, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE TECHNICIAN KINKED THE PC400 COIL PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN REMOVED BOTH THE PC400 COIL AND THE PX SLIM FROM THE PATIENT AND THEN DECIDED TO DOWNSIZE HIS SYSTEM. THERE WERE NO REPORTED ISSUES WITH THE PX SLIM. THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL AND A NEW MICROCATHETER FROM ANOTHER MANUFACTURER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5585755 ↗
• InjurySep 30, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR CEREBRAL ARTERY (ACA)-ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THIRTEEN PC400 COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED INTO THE ANEURYSM WITH NO COMPLICATIONS. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A SEVERE ISCHEMIC STROKE IN THE LEFT ANTERIOR CEREBRAL ARTERY. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), MAGNETIC RESONANCE IMAGING (MRI), ELECTROENCEPHALOGRAM (EEG), TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE PERFORMED AND THE PATIENT WAS TREATED WITH SIMVASTATIN. THE REPORTED ISCHEMIC STROKE RESOLVED ON (B)(6) 2013.

  Patient problems: Infarction, Cerebral

  MAUDE report 5114284 ↗