Penumbra Coil 400 4002C1450-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548019215), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENTS ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S IN THE TARGET VESSEL USING THE PX SLIM. THEN, AFTER ADVANCING THE NEXT PC400 THROUGH THE PX SLIM WITH RESISTANCE TO THE TARGET VESSEL, THE PHYSICIAN RETRACTED THE PC400 FOR REPOSITIONING SEVERAL TIMES. IT WAS REPORTED THAT THE PHYSICIAN ALSO FELT RESISTANCE WHILE RETRACTING THE PC400 FROM THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO NOT IMPLANT THE PC400. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177929 ↗