Penumbra Coil 400 4006C0306-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548018188), received between Jan 12, 2024 and Jan 12, 2024 — classified as 1 injury.

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.

• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN ORIGIN OF THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PC400 AND REPORTED THAT THE COIL UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 AND FLUSHED THE COIL OUT OF THE PX SLIM USING A THREE ML SYRINGE.THE PHYSICIAN THEN RE-INTRODUCED THE SAME PX SLIM INTO THE TARGET LOCATION AND ATTEMPTED TO IMPLANT ANOTHER PC400. WHILE RETRACTING THE PC400 FOR RE-POSITIONING, THE PCOM DISSECTED CAUSING THROMBOSIS OF THE ANEURYSM AND PART OF THE PCOM. THEREFORE, THE PC400 WAS REMOVED INTACT. THE PHYSICIAN THEN ADMINISTERED AN ANTIPLATELET DRUG. THE PROCEDURE WAS ENDED AT THIS POINT.

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 18509139 ↗