Penumbra Coil 400 4002C0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244002C04080), received between Dec 21, 2015 and Jul 26, 2016 — classified as 2 injuries.

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.

• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (ICA-PCOM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, AFTER EIGHT PC400 COILS WERE DEPLOYED AND DETACHED IN THE ANEURYSM, MINIMAL THROMBUS FORMATION WAS NOTED AT THE ANEURYSM NECK. THEREFORE, THE PATIENT WAS ADMINISTERED FOUR THOUSAND UNITS OF HEPARIN AND SUBSEQUENTLY, THE THROMBUS RESOLVED. THE REPORTED MINIMAL THROMBUS FORMATION WAS ADJUDICATED TO HAVE A DEFINITE RELATIONSHIP TO THE PC400 COIL SYSTEM, AN UNRELATED RELATIONSHIP TO THE PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE DISEASE STATE.

  Patient problems: Thrombus

  MAUDE report 5823731 ↗
• InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT POSTERIOR INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS USING THE PX SLIM. THE FOLLOWING DAY, THE PATIENT EXPERIENCED A SEVERE RIGHT POSTERIOR LIMBIC STROKE. THE EVENT REMAINED UNRESOLVED AND NO ACTIONS WERE TAKEN. THE REPORTED RIGHT POSTERIOR LIMBIC STROKE WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS AND A POSSIBLE RELATIONSHIP TO THE PX SLIM, ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM STATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 5317273 ↗