Penumbra Coil 400 4002C1135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244002C11350), received between Sep 23, 2016 and Apr 15, 2021 — classified as 2 injuries.

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

• InjuryApr 15, 2021Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400), PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NON-PENUMBRA EMBOLIZATION DEVICE. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PX SLIM BEHIND THE EMBOLIZATION DEVICE AND PLACED TWO PC400S IN THE ANEURYSM. WHILE ADVANCING ANOTHER PC400 AS THE THIRD COIL, THE PHYSICIAN EXPERIENCED RESISTANCE INSIDE THE ANEURYSM FROM THE PACKING DENSITY OF THE PREVIOUSLY PLACED PC400S. THE PHYSICIAN THEN PULLED THE PC400 IN AN ATTEMPT TO REMOVE IT; HOWEVER, THE PC400 HAD UNINTENTIONALLY DETACHED WITH APPROXIMATELY FIVE CENTIMETERS OF THE PC400 IN THE ANEURYSM AND THE REST OF THE COIL WAS WITHIN THE MICROCATHETER. SUBSEQUENTLY, WHILE PULLING THE PC400, THE COIL BECAME STRETCHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE REMAINING PC400 OUT OF THE MICROCATHETER AND AORTA; THEN USED ASPIRATION TO SUCCESSFULLY REMOVE THE REMAINING PC400. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT DUE TO ACCESS WITH THE PX SLIM WAS LOST. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675831 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE LEFT PERIOPHTHALMIC ARTERY USING PENUMBRA COIL 400 (PC400'S) WITH NO COMPLICATIONS DURING THE PROCEDURE. HOWEVER, SIX HOURS POST-PROCEDURE, THE PATIENT DEVELOPED APHASIA, WHICH PROGRESSED TO RIGHT-SIDED WEAKNESS. A FOLLOW-UP ANGIOGRAPHY WAS PERFORMED AND SHOWED DECREASE BLOOD FLOW INTO THE MIDDLE CEREBRAL ARTERY (MCA) AND A THROMBUS IN THE M3 BRANCH OF THE LEFT INTERNAL CAROTID ARTERY (LICA) WAS NOTICED. THEREFORE, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE, WHICH PARTIALLY REMOVED THE THROMBUS; HOWEVER, A FRAGMENT OF THE THROMBUS WENT DOWNSTREAM AND COULD NOT BE REMOVED. THE PATIENT WAS STILL ADMITTED IN THE HOSPITAL. AS OF (B)(6) 2016, THE PATIENT WAS IN STABLE CONDITION. THIS SERIOUS ADVERSE EVENT WAS REPORTED AS AN ISCHEMIC STROKE AND WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE PC400'S, THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM MALFORMATION.

  Patient problems: Dysphasia; Thrombus; Weakness

  MAUDE report 5975393 ↗