Penumbra Coil 400 4002C0820Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M4244002C08200), received between Sep 25, 2015 and Sep 23, 2016 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 4 most recent of 4 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 5975455 ↗
• MalfunctionMar 16, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM INTO THE GUIDE CATHETER, THE PHYSICIAN NOTICED THAT THE STRAIN RELIEF OF THE PX SLIM HAD UNRAVELED AND DECIDED TO REMOVE THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW PX SLIM FOR THE PROCEDURE; HOWEVER, IT WAS NOT LONG ENOUGH TO REACH THE TARGET VESSEL AND WAS REMOVED. THE PHYSICIAN THEN DEPLOYED A PC400 COIL INTO THE ANEURYSM USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY); HOWEVER, THE PC400 COIL FAILED TO DETACH USING THE PENUMBRA COIL DETACHMENT HANDLE (HANDLE) AND WAS REMOVED. NEXT, THE PHYSICIAN DEPLOYED A NEW PC400 COIL INTO THE ANEURYSM USING THE VELOCITY BUT DID NOT LIKE THE WAY THE COIL WAS FILLING THE ANEURYSM SO HE DECIDED TO REMOVE THE COIL. WHILE THE PC400 COIL WAS BEING WITHDRAWN, IT UNINTENTIONALLY DETACHED WITHIN THE ROTATING HEMOSTASIS VALVE (RHV). THERE WAS NO REPORT OF FRICTION OR RESISTANCE. THE DETACHED PC400 COIL AND VELOCITY WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5504143 ↗
• MalfunctionMar 16, 2016Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM INTO THE GUIDE CATHETER, THE PHYSICIAN NOTICED THAT THE STRAIN RELIEF OF THE PX SLIM HAD UNRAVELED AND DECIDED TO REMOVE THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW PX SLIM FOR THE PROCEDURE; HOWEVER, IT WAS NOT LONG ENOUGH TO REACH THE TARGET VESSEL AND WAS REMOVED. THE PHYSICIAN THEN DEPLOYED A PC400 COIL INTO THE ANEURYSM USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY); HOWEVER, THE PC400 COIL FAILED TO DETACH USING THE PENUMBRA COIL DETACHMENT HANDLE (HANDLE) AND WAS REMOVED. NEXT, THE PHYSICIAN DEPLOYED A NEW PC400 COIL INTO THE ANEURYSM USING THE VELOCITY BUT DID NOT LIKE THE WAY THE COIL WAS FILLING THE ANEURYSM SO HE DECIDED TO REMOVE THE COIL. WHILE THE PC400 COIL WAS BEING WITHDRAWN, IT UNINTENTIONALLY DETACHED WITHIN THE ROTATING HEMOSTASIS VALVE (RHV). THERE WAS NO REPORT OF FRICTION OR RESISTANCE. THE DETACHED PC400 COIL AND VELOCITY WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5504070 ↗
• MalfunctionSep 25, 2015Difficult or Delayed Positioning

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY DETACHING A PC400 COIL INTO THE ANEURYSM, BUT IT DID EVENTUALLY DETACH. HOWEVER, TWO NEW PC400 COILS FAILED TO DETACH AND WERE SUCCESSFULLY REMOVED. THE PROCEDURE CONTINUED USING 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 5105570 ↗