Penumbra Coil 400 4004C1135Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244004C11350), received between Aug 27, 2015 and Nov 11, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC 400) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PC400 INTO THE TARGET LOCATION, THE PC400 UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE PC400. THE PROCEDURE WAS COMPLETED USING A RUBY COIL 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 12800632 ↗
• MalfunctionSep 24, 2018Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE PC400 BECAME KINKED. THE PHYSICIAN THEREFORE REMOVED THE PC400, AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902663 ↗
• MalfunctionFeb 18, 2016Kinked; Human Factors Issue; Device Handling Problem; Kinked; Human Factors Issue; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HYPOTUBE SHAFT ON THE PENUMBRA COIL 400 COIL (PC400 COIL) BECAME KINKED AFTER THE COIL WAS REMOVED FROM ITS PACKAGING AND WAS HANDED OFF TO THE RADIOLOGIC TECHNOLOGIST. THE DAMAGED PC400 COIL WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW PC400 COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5444976 ↗
• MalfunctionFeb 10, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A PC400 COIL INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO DELIVER A NEW PC400 COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL INTO THE PX SLIM AND REMOVED THE COIL. THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL 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 5426989 ↗
• MalfunctionAug 27, 2015Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400) COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE ADVANCING THE PC400 COIL THROUGH THE PX SLIM. UPON RETRACTION, THE PHYSICIAN NOTICED THAT THE COIL WOULD NOT RETRACT WITH THE PUSHERWIRE. THE PHYSICIAN REMOVED THE PX SLIM WITH THE PC400 COIL INSIDE. THE PC400 WAS REMOVED AND THE PROCEDURE CONTINUED SUCCESSFULLY USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5036733 ↗