Penumbra Coil 400 4002C1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244002C10300), received between Dec 1, 2015 and Sep 23, 2016 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• 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 PARAOPHTHALAMIC 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 5975422 ↗
• DeathDec 1, 2015Device Operates Differently Than Expected

  THE PATIENT SUCCESSFULLY UNDERWENT A COIL EMBOLIZATION PROCEDURE FOR A RUPTURED SACCULAR ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA) USING FOUR PENUMBRA COILS 400 (PC400 COILS). A THREE MONTHS POST-PROCEDURE FOLLOW UP VISIT CONFIRMED RECANALIZATION OF THE ANEURYSM. A SIX MONTH POST-PROCEDURE FOLLOW-UP VISIT CONFIRMED THE NEED FOR RE-TREATMENT OF THE ANEURYSM. HOWEVER, THREE DAYS PRIOR TO THE SCHEDULED RE-TREATMENT SURGERY, THE ANEURYSM RE-BLED AND THE PATIENT EXPIRED. THE SERIOUS ADVERSE EFFECT:DEATH, WAS ADJUDICATED TO HAVE A POSSIBLE RELATIONSHIP TO THE PC400 SYSTEM, AN UNRELATED RELATIONSHIP TO ANGIOGRAPHIC PROCEDURE, AND A DEFINITE RELATIONSHIP TO ANEURYSM DISEASE STATE.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 5257571 ↗