Penumbra Coil 400 4004C1440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244004C14400), received between Nov 10, 2017 and Dec 29, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionDec 29, 2020Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN COILS IN THE TARGET VESSEL. THE EIGHTH COIL, A PC400, WAS THEN BEING PLACED. WHILE ATTEMPTING TO PUSH THE PUSHER ASSEMBLY OF THE PC400, THE PHYSICIAN FELT RESISTANCE IN THE MICROCATHETER DESPITE THE PC400 WAS PROPERLY SHAPED IN THE ANEURYSM. WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE PC400 USING THE HANDLE, THE PC400 DID NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN RECAPTURED THE PC400 INTO THE PX SLIM. IT WAS OBSERVED THAT THE PC400 UNINTENTIONALLY DETACHED IN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW COILS AND THE SAME HANDLE AND PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11085867 ↗
• MalfunctionApr 25, 2018Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE USING PENUMBRA COILS 400 (PC400¿S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE HOSPITAL FELLOW WAS TOO AGGRESSIVE AND INADVERTENTLY BENT THE PC400 PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT ANOTHER PC400 PUSHER ASSEMBLY WAS ALSO BENT WHILE ADVANCING THE PC400 THROUGH THE PX SLIM; THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL COILS. AROUND THE 30TH COIL, IT WAS REPORTED THAT BLOOD MIGHT HAVE GOTTEN INSIDE THE HANDLE AND ITS THE TRIGGER BECAME A BIT STICKY; THEREFORE, THE HANDLE WAS SET ASIDE. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM, A NEW HANDLE AND ADDITIONAL PC400'S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7461671 ↗
• MalfunctionNov 10, 2017Bent; Break; Physical Resistance; Bent; Break; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO INTRODUCE A PC400 INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 PUSHER ASSEMBLY BECAME BENT THEN BROKE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 11 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 7022356 ↗