Penumbra Coil 400 4004C0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244004C04080), received between Jan 13, 2016 and Aug 14, 2017 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PC400S USING THE HANDLE. THE PHYSICIAN WAS THEN UNABLE TO DETACH A PC400 USING THE SAME HANDLE; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400, THE SAME HANDLE, AND THE SAME PX SLIM DELIVERY MICROCATHETER (PX SLIM). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6793228 ↗
• InjuryJul 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, AFTER DELIVERING THE SECOND PC400 IN THE ANEURYSM, PERFORATION OF THE ANEURYSM SAC WAS OBSERVED. THE BLEEDING LASTED APPROXIMATELY FIVE MINUTES AS THE PERFORATION WAS SEALED BY IMPLANTING A THIRD PC400. NO FURTHER TREATMENT WAS REQUIRED FOR THE BLEEDING AND POST-PROCEDURE NEUROLOGICAL EXAMINATION WAS NORMAL. ON (B)(6) 2016, THIS ADVERSE EVENT WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 SYSTEM AND A POSSIBLE RELATIONSHIP TO BOTH THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM DISEASE STATE.

  Patient problems: Blood Loss; Perforation of Vessels

  MAUDE report 5796867 ↗
• MalfunctionJan 13, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 COIL OUT OF ITS INTRODUCER SHEATH AND INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PC400 COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW PC400 COILS 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 5365631 ↗