Penumbra Coil 400 400PAC50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948021341), received between Sep 26, 2019 and Mar 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Fold” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PAC400. DURING THE PROCEDURE, A PAC400 WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, THE PAC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547038 ↗
• MalfunctionSep 26, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL VENOUS SINUS USING PAC400S (PAC400). DURING THE PROCEDURE, AFTER ADVANCING A PAC400 INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN DECIDED TO RETRACT THE PAC400 FOR REPOSITIONING. HOWEVER, WHILE RETRACTING, THE PAC400 UNINTENTIONALLY DETACHED FROM THE PUSHER WIRE INSIDE OF THE PX SLIM. THEREFORE, THE PHYSICIAN USED A 20CC SYRINGE TO CREATE NEGATIVE PRESSURE AND REMOVED THE PX SLIM WITH THE COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW PAC400 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 9126493 ↗