Penumbra Coil 400 4006C0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244006C03080), received between Sep 30, 2015 and May 11, 2021 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE THIRD COIL, A PC400, WAS UNABLE TO BE ADVANCED INTO THE PX SLIM AND RESISTANCE WAS NOTED. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806691 ↗
• MalfunctionJun 7, 2016Detachment Of Device Component; Premature Activation; Malposition of Device; Detachment Of Device Component; Premature Activation; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL VERTEBRAL ARTERY (DVA) USING PENUMBRA COIL 400 COILS (PC400 COILS). PRIOR TO PLACING COILS INTO THE PATIENT, THE PHYSICIAN IMPLANTED THREE FLOW DIVERTING STENTS FROM ANOTHER MANUFACTURER VIA THE RIGHT VERTEBRAL ARTERY. THE ANEURYSM SAC WAS THEN ACCESSED VIA THE LEFT VERTEBRAL ARTERY FOR COIL EMBOLIZATION. WHILE ATTEMPTING TO ADVANCE AN INITIAL PC400 COIL INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN HAD DIFFICULTY ADVANCING THE COIL OUT OF ITS INTRODUCER SHEATH. UPON FURTHER MANIPULATION, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE PC400 COIL AND THEREFORE, THE COIL WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL PC400 COILS. WHILE ATTEMPTING TO PLACE THE LAST PC400 COIL INTO THE DVA, THE PHYSICIAN RETRACTED THE COIL AND SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED. THE PC400 COIL EXTENDED DOWN FROM THE VERTEBRAL/BASILAR JUNCTION APPROXIMATELY SIX CENTIMETERS TO THE PROXIMAL VERTEBRAL ARTERY. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO IMMEDIATE ADVERSE EFFECTS NOTED. THE PATIENT HAD A FOLLOW UP ANGIOGRAM TWO DAYS POST PROCEDURE WHICH REVEALED THAT THE PC400 COIL WAS STILL IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5704005 ↗
• 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 5114238 ↗