Penumbra Coil 400 4002C1335Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244002C13350), received between Jul 7, 2017 and Feb 16, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103305); they may or may not involve this specific model.

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.

• MalfunctionFeb 16, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT THE PENUMBRA COIL 400 (PC400) PUSHER ASSEMBLY WAS KINKED AND THE COIL WAS DETACHED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE PC400 WAS NOTICED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Patient Involvement

  MAUDE report 7277542 ↗
• MalfunctionJul 7, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE AN INITIAL PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) BUT THE COIL WOULD NOT ADVANCE OUT. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NINE NEW PC400S 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 6693175 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103305. One submission often covers many models, so check the product and lot details in each record.

• Z-1906-2011 · Mar 4, 2011 · Terminated
  Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is in