Penumbra Coil 400 4006C0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244006C04100), received between Sep 30, 2015 and Feb 1, 2017 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, A PC400 UNINTENTIONALLY DETACHED AFTER ADVANCING THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN WAS ABLE TO RETRIEVE THE COIL USING A NON-PENUMBRA STENT RETRIEVER, AND THEN COMPLETED THE PROCEDURE USING THE SAME PX SLIM AND ADDITION PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6295005 ↗
• InjuryOct 13, 2016Detachment Of Device Component; Migration or Expulsion of Device; Detachment Of Device Component; Migration or Expulsion of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID ARTERY USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) INTO THE CAROTID ARTERY AND THEN ADVANCED ANOTHER MANUFACTURER'S MICROWIRE AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE TARGET VESSEL. WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN DID NOT MENTION EXPERIENCING RESISTANCE OR DIFFICULTY. AFTER DEPLOYING APPROXIMATELY SEVEN CENTIMETERS OF A PC400 INTO THE ANEURYSM, THE PHYSICIAN REALIZED THAT ONE OF THE COIL'S LOOP WAS OUTSIDE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400 IN ORDER TO REPOSITION IT. HOWEVER, WHILE THE PC400 WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE PATIENT'S BODY. SUBSEQUENTLY, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE REMAINING PORTION OF THE DETACHED COIL INTO THE ANEURYSM. HOWEVER, UPON REMOVAL OF THE PX SLIM, THE DETACHED PC400 MIGRATED OUT OF THE ANEURYSM AND INTO THE MIDDLE CEREBRAL ARTERY (MCA). CONSEQUENTLY, THE MCA BECAME OCCLUDED DUE TO THE DETACHED PC400. THE PHYSICIAN THEN DECIDED TO PLACE ANOTHE

  Patient problems: Neurological Deficit/Dysfunction; Occlusion; Paralysis

  MAUDE report 6028616 ↗
• MalfunctionJul 8, 2016Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A PC400 COIL INTO THE ANEURYSM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO RETRACT THE COIL TO REPOSITION IT. HOWEVER, WHILE THE COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED WITHOUT ANY "SNAP" OR SIGNIFICANT PULLING, INSIDE THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). WITH SEVERAL CENTIMETERS OF THE COIL ALREADY IN THE ANEURYSM, THE PHYSICIAN THEN CAREFULLY PULLED THE PX SLIM OUT OF THE PATIENT AND WAS ABLE TO PULL THE ENTIRE PC400 COIL OUT WITH IT WITHOUT AN ISSUE. THE PROCEDURE WAS STOPPED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5780219 ↗
• InjuryDec 11, 2015Detachment Of Device Component; Entrapment of Device; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION FOR A FISTULA USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE IN USE WITH A BENCHMARK DELIVERY CATHETER (BENCHMARK DC) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN DEPLOYED AND DETACHED A PC400 COIL INTO THE FISTULA WITHOUT ANY ISSUES. WHILE ADVANCING A NEW PC400 COIL, THROUGH THE PX SLIM, THE COIL KICKED THE PX SLIM OUT OF THE FISTULA SPACE, WHICH IN TURN, KICKED THE BENCHMARK DC OUT; SUBSEQUENTLY, THE PC400 COIL UNINTENTIONALLY DETACHED AND PART OF THE COIL WAS IN THE PX SLIM WHILE PART OF IT WAS DEPLOYED IN THE SPACE THAT THEY WERE EMBOLIZING. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE DETACHED COIL OUT OF THE PATIENT BUT WAS UNSUCCESSFUL. THE PHYSICIAN INDICATED THAT THERE WAS NO OTHER GOOD OPTION TO RETRIEVE THE COIL AND DID NOT BELIEVE THAT THE DETACHED COIL WOULD CAUSE ANY HARM TO THE PATIENT SO IT WAS LEFT IN THE PETROSAL VEIN AND THE CAVERNOUS SINUS. WHILE THE PATIENT WAS UNDERGOING AN EXAM TO GET HER READY FOR A BALLOON TEST OCCLUSION (BTO), SHE EXPERIENCED A STROKE AND HER CAVERNOUS ANEURYSM RUPTURED. THE PATIENT HAD LABILE BLOOD PRESSURE AND THE HOSPITAL STAFF BELIEVED THAT SHE EXPERIE

  Patient problems: Device Embedded In Tissue or Plaque; Ischemia; Rupture

  MAUDE report 5291798 ↗
• InjurySep 30, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR CEREBRAL ARTERY (ACA)-ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THIRTEEN PC400 COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED INTO THE ANEURYSM WITH NO COMPLICATIONS. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A SEVERE ISCHEMIC STROKE IN THE LEFT ANTERIOR CEREBRAL ARTERY. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), MAGNETIC RESONANCE IMAGING (MRI), ELECTROENCEPHALOGRAM (EEG), TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE PERFORMED AND THE PATIENT WAS TREATED WITH SIMVASTATIN. THE REPORTED ISCHEMIC STROKE RESOLVED ON (B)(6) 2013.

  Patient problems: Infarction, Cerebral

  MAUDE report 5114227 ↗