Penumbra Coil 400 4004C1645Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M4244004C16450), received between Jun 17, 2016 and Jun 17, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2016Failure to Advance; Physical Resistance; Activation, Positioning or Separation Problem; Failure to Advance; Physical Resistance; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A PELVIC ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 COIL INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER''S MICROCATHETER. HOWEVER, THE COIL WAS NOT FRAMING PROPERLY AND WAS THEREFORE, REMOVED FROM THE PATIENT. UPON ATTEMPTING TO REDEPLOY THE SAME PC400 COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF THE MICROCATHETER. THEREFORE, THE PC400 COIL WAS REMOVED 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 5732817 ↗