Penumbra Coil 400 4004C0509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M4244004C05090), received between Sep 18, 2015 and Apr 1, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE DETACHED PC400 AND THEN REMOVED THE PC400. 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 Consequences Or Impact To Patient

  MAUDE report 9911055 ↗
• MalfunctionNov 24, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A PC400 WITHIN A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND, CONSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER AND NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100122 ↗
• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (ICA-PCOM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, AFTER EIGHT PC400 COILS WERE DEPLOYED AND DETACHED IN THE ANEURYSM, MINIMAL THROMBUS FORMATION WAS NOTED AT THE ANEURYSM NECK. THEREFORE, THE PATIENT WAS ADMINISTERED FOUR THOUSAND UNITS OF HEPARIN AND SUBSEQUENTLY, THE THROMBUS RESOLVED. THE REPORTED MINIMAL THROMBUS FORMATION WAS ADJUDICATED TO HAVE A DEFINITE RELATIONSHIP TO THE PC400 COIL SYSTEM, AN UNRELATED RELATIONSHIP TO THE PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE DISEASE STATE.

  Patient problems: Thrombus

  MAUDE report 5824132 ↗
• InjurySep 18, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY USING PENUMBRA COIL 400 (PC400) COILS. THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. HOWEVER, THE NEXT DAY, MAGNETIC RESONANCE IMAGING REVEALED SMALL FOCI OF SILENT ISCHEMIA IN THE LEFT CEREBRAL HEMISPHERE OF THE PATIENT. THE RELATIONSHIP OF THE PC400 COILS TO THE ISCHEMIA IS UNCERTAIN; HOWEVER THE RELATIONSHIP OF THE PROCEDURE TO THE ISCHEMIA IS DEFINITE.

  Patient problems: Ischemia

  MAUDE report 5089326 ↗