Penumbra Coil 400 4004C1845Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244004C18450), received between Jun 10, 2016 and May 9, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2018Out-Of-Box Failure; Device Handling Problem; Out-Of-Box Failure; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY DROPPED THE PEUNUMBRA COIL 400 (PC400) ON THE FLOOR UPON REMOVAL FROM THE PACKAGING. THE REPORTED ISSUE WAS FOUND PRIOR TO USE AND THEREFORE, THE PC400 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Patient Involvement

  MAUDE report 7498950 ↗
• MalfunctionJun 10, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO PC400 COILS THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, BOTH PC400 COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW PC400 COILS 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 5717032 ↗