Penumbra Coil 400 4004C1020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244004C10200), received between Sep 25, 2015 and Oct 12, 2017 — classified as 2 malfunctions.

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

• MalfunctionOct 12, 2017Device Damaged Prior to Use; Component Missing; Out-Of-Box Failure; Device Damaged Prior to Use; Component Missing; Out-Of-Box Failure

  WHILE PREPARING A PENUMBRA COIL 400 (PC400) FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF OPENED THE PACKAGING AND NOTICED THAT THE PC400 EMBOLIZATION COIL WAS MISSING. THE MISSING EMBOLIZATION COIL WAS NOTICED PRIOR TO USE AND THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER PC400.

  Patient problems: No Patient Involvement

  MAUDE report 6945328 ↗
• MalfunctionSep 25, 2015Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400 COIL). DURING THE PROCEDURE WHILE DEPLOYING THE PC400 COIL IN THE ANEURYSM, THE COIL UNINTENTIONALLY DETACHED AND CAUSED OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY, RESULTING IN A RIGHT SIDE HEMIPLEGIA. A STENT RETRIEVER WAS USED TO REMOVE THE PC400 COIL. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400 COIL TO THE ANEURYSM BUT MET RESISTANCE AND THE COIL WAS REMOVED; THE PROCEDURE DID NOT CONTINUE ANY FURTHER.

  Patient problems: Occlusion; Paresis

  MAUDE report 5105844 ↗