Penumbra Coil 400 4006C0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M4244006C03100), received between Sep 25, 2015 and Sep 25, 2015 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2015Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400 COIL) AND A RUBY COIL. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PC400 COIL THROUGH A PX SLIM AND REMOVED IT. AFTER SUCCESSFULLY DEPLOYING A NEW PC400 COIL INTO THE ANEURYSM IT FAILED TO COIL IN THE PROPER MANNER AND WAS REMOVED FROM THE PATIENT. DURING THE THIRD ATTEMPT THE PHYSICIAN USED A RUBY COIL WHICH BENT UPON ADVANCING IT THOUGH A PX SLIM. THE RUBY COIL WAS REMOVED AND WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW RUBY COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5105143 ↗