Penumbra Coil 400 4006C0303Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244006C03030), received between Dec 6, 2016 and Jul 29, 2021 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT VERTEBRAL ARTERIOVENOUS FISTULA (AVF) USING PENUMBRA COIL 400S (PC400S), A NON-PENUMBRA COIL, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL AND A PC400. WHILE ADVANCING THE NEXT PC400 THROUGH THE MICROCATHETER, THE PC400 BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PC400. UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED. AFTER REMOVAL OF THE MICROCATHETER, A GOOD THROMBOSIS WAS NOTICED IN THE AVF. THEREFORE, THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249719 ↗
• MalfunctionJan 12, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A PENUMBRA COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 USING THE HANDLE AFTER ADVANCING THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ADVANCED THE PC400 INTO THE TARGET LOCATION THROUGH THE PX SLIM AND ATTEMPTED TO DETACH THE PC400 USING THE SAME HANDLE, HOWEVER THE PC400 DID NOT DETACH, DESPITE THE BLACK PET LOCK BEING SEPARATED. THE PHYSICIAN THEREFORE ATTEMPTED TO MANUALLY DETACH THE COIL BY PULLING ON THE NITINOL WIRE, AND THEN BY BREAKING THE HYPOTUBE TO ATTEMPT TO DETACH THE COIL, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN FLUSHED AND JIGGLED THE PX SLIM AND PULL WIRE, EVENTUALLY CAUSING THE PC400 TO DETACH. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THIS WAS THE LAST COIL NEEDED. IT WAS REPORTED THAT THERE WAS EXCESSIVE TORTUOSITY WITHIN THE ENTIRE INTERNAL CAROTID ARTERY (ICA), FROM THE LOW CERVICAL ALL THE WAY UP TO THE BIFURCATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186717 ↗
• MalfunctionDec 6, 2016Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance; Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400¿S (PC400). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A MICRO GUIDEWIRE IN THE PATIENT¿S BODY. ALTHOUGH THE MICRO GUIDEWIRE ADVANCED TOWARD THE TARGET PORTION OF THE IMA, THE PX SLIM WOULD NOT ADVANCE SMOOTHLY. THEREFORE, THE MICRO GUIDEWIRE WAS REMOVED AND REPLACED WITH ANOTHER GUIDEWIRE AND THE PHYSICIAN ADVANCED A 3 MILLIMETERS PC400 INTO THE ANEURYSM. HOWEVER, DUE TO THE LARGE SIZE OF THE ANEURYSM, THE PC400 DID NOT PROPERLY FILL THE ANEURYSM; THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH IT. WHILE RETRACTING THE PC400 COIL THROUGH THE PX SLIM IN ORDER TO RESHEATH IT, THE PHYSICIAN FIRST EXPERIENCED RESISTANCE AND THEN NO RESISTANCE WAS EXPERIENCED AFTERWARD. SUSPECTING THE POSSIBILITY OF AN UNINTENTIONAL DETACHMENT OF THE PC400 IN THE PX SLIM, THE PHYSICIAN PERFORMED AN ANGIOGRAPHY WHICH CONFIRMED THAT THE PC400 HAD UNINTENTIONALLY DETACHED NEAR THE HUB OF THE PX SLIM. AFTER AN UNSUCCESSFULLY ATTEMPTED TO PUSH THE DETACHED PC400 OUT OF THE PX SLIM AND INTO THE ANEURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149813 ↗