Penumbra Coil 400 4006C0406-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548018218), received between Jan 29, 2021 and Oct 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionOct 20, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400S (PC400S), PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLE), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO PC400S USING THE HANDLE. AFTER ADVANCING THE THIRD PC400 INTO THE TARGET LOCATION AND MAKING SEVERAL ATTEMPTS TO DETACH THE PC400 USING THE HANDLE, THE COIL FAILED TO DETACH. WHILE RETRACTING THE PUSHER ASSEMBLY OF THE PC400, THE PC400 WAS PULLED BACK INTO THE PX SLIM AND SUBSEQUENTLY UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT, AND THE DEVICES WERE NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN ADVANCED ANOTHER PC400 INTO THE TARGET LOCATION USING A NEW PX SLIM AND ATTEMPTED TO DETACH THE COIL USING A SECOND HANDLE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE SUCCESSFULLY DETACH THE PC400. IT WAS REPORTED THAT ONE LOOP OF THE PC400 WAS EXTRUDING FROM THE ANEURYSM; HOWEVER, THE PHYSICIAN DOES NOT BELIEVE IT WOULD RESULT IN ANY CLINICAL CONSEQUENCE AND NO FURTHER ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17972054 ↗
• MalfunctionJan 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND EXTERNAL CAROTID ARTERY (ECA) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE POD COILS IN THE TARGET VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO INSERT THE FOURTH COIL, A PC400, INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PENUMBRA COILS 400 (PC400S), POD COILS, AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11254281 ↗