Penumbra Coil 400 4004C0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244004C03100), received between Aug 15, 2018 and Jul 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionJul 18, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN PC400S USING THE PX SLIM. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PC400 WAS REMOVED FROM THE PX SLIM OUTSIDE OF THE PATIENT AND THE PX SLIM WAS REINSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PC400 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 15048228 ↗
• MalfunctionAug 15, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SINUS TRANSVERSUS USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN COILS IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ADVANCED A NEW PC400 INTO THE TARGET VESSEL BUT DID NOT LIKE THE COIL POSITION; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-INTRODUCE THE SAME PC400, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE PC400 WOULD NOT ADVANCE INTO THE PX SLIM; THEREFORE, IT WAS REMOVED. IT REPORTED THAT THE PHYSICIAN DID NOT RINSE THE PC400 IN SALINE PRIOR TO RE-USING IT. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER PC400 IN THE TARGET VESSEL USING THE SAME PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 INTO THE PX SLIM BUT THE PC400 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT ADDITIONAL PC400S 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 7785833 ↗