Penumbra Coil 400 4004C0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244004C08300), received between Sep 3, 2015 and Jul 14, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2016Failure to Fold; Structural Problem; Device Operates Differently Than Expected; Failure to Fold; Structural Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 COIL INTO THE ANEURYSM; HOWEVER, THE COIL WAS NOT TAKING THE INTENDED 3D COILING PATTERN. SUBSEQUENTLY, THE PC400 COIL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ADVANCED THE COIL OUT INTO A BOWL OF SALINE AND FOUND THAT IT CAME OUT STRAIGHT AND DID NOT COIL INTO A 3D PATTERN. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL AND ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5797012 ↗
• MalfunctionFeb 5, 2016Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THREE PC400 COILS INTO THE ANEURYSMATIC SAC. A FOURTH PC400 COIL (LOT # F43753) WAS THEN DEPLOYED INTO THE PATIENT; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE (LOT # F42954) EVEN AFTER MANUALLY PULLING BACK ON THE PC400 COIL PUSHER ASSEMBLY. THE PC400 COIL WAS REMOVED FROM THE PATIENT AND A FIFTH PC400 COIL (LOT # F63337) WAS DEPLOYED. HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THIS FIFTH COIL USING A NEW HANDLE (LOT # F62622) AND REMOVED THE COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S COILS. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. THERE WAS A TIGHT CORNER OF ABOUT 150 DEGREES AT THE BEGINNING OF THE SUPERIOR MESENTERIC ARTERY THROUGH ANOTHER MANUFACTURER'S MICROCATHETER AND AFTER THAT, THERE WAS A LONG AND TORTUOUS PATH THROUGH THE RIOLANO CIRCULATION TO THE ANEURYSMATIC SAC IN THE INFERIOR MESENTERIC ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5414136 ↗
• MalfunctionSep 3, 2015Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A PENUMBRA COIL 400 (PC400) COILS AND A PENUMBRA COIL 400 DETACHMENT HANDLE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED THE FIRST PC400 COIL USING THE DETACHMENT HANDLE. THE PHYSICIAN ADVANCED A SECOND PC400 COIL INTO THE ANEURYSM; HOWEVER, IT WOULD NOT DETACH USING THE DETACHMENT HANDLE. THE PC400 COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN REQUIRED MULTIPLE ATTEMPTS TO MANUALLY DETACH IT OUTSIDE THE PATIENT. THE PHYSICIAN USED A THIRD PC400 COIL WHICH HE WAS UNABLE TO DETACH USING THE DETACHMENT HANDLE, BUT WAS ABLE TO MANUALLY DETACH FROM THE PUSHER WIRE INTO THE ANEURYSM. THE PROCEDURE CONTINUED USING A NEW (FOURTH) PC400 COIL AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5054667 ↗