Penumbra Coil 400 4006C0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244006C03040), received between Mar 11, 2016 and Mar 8, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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.

• MalfunctionMar 8, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE PC400 IN THE ANEURYSM USING THE PX SLIM. WHILE ADVANCING ANOTHER PC400 TO THE ANEURYSM USING THE PX SLIM, THE PHYSICIAN PULLED THE PC400 BACK TO REPOSITION IT. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED IN THE PX SLIM WITH HALF OF THE COIL IN THE ANEURYSM. THEREFORE, THE PHYSICIAN USED A 60CC SYRINGE TO SUCCESSFULLY ASPIRATE THE DETACHED PC400 FROM THE PX SLIM AND THEN REMOVED THE PX SLIM. IT SHOULD BE NOTED THAT THERE WAS NO REPORTED ISSUE WITH THE PX SLIM. THE PROCEDURE WAS COMPLETED USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688407 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400''S (PC400''S) WITH NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2017, THE PATIENT PRESENTED AT THE HOSPITAL WITH A RIGHT ARM AND LEG SENSATION CHANGE. THE RIGHT ARM SENSATION RESOLVED SPONTANEOUSLY; HOWEVER, THE PATIENT HAD DECREASED SENSATION BELOW THE KNEE AND A COLD FEELING WAS PRESENT. THE PATIENT''S NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE AT BASELINE WAS A 3. THE RESULTS OF THE COMPUTERIZED TOMOGRAPHY (CT) HEAD AND COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE NEGATIVE AT BASELINE. THE PATIENT WAS GIVEN INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV-TPA) AND THE SYMPTOMS RESOLVED ON (B)(6) 2017. THE REPORTED FOCAL NEUROLOGICAL DEFICIT WAS ADJUDICATED TO BE AN ADVERSE EVENT THAT WAS POSSIBLY RELATED TO THE PC400 BUT UNRELATED TO THE PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7033675 ↗
• MalfunctionAug 4, 2016Detachment Of Device Component; Stretched; Detachment Of Device Component; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL PC400 COILS INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE DEPLOYING THE LAST PC400 COIL, THE PHYSICIAN RETRACTED THE COIL IN ORDER TO REPOSITION IT; HOWEVER, IT BECAME STRETCHED AND THEN UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE WHILE ADVANCING OR RETRACTING THE LAST PC400 COIL THROUGH THE PX SLIM. THE PX SLIM CONTAINING THE DETACHED PC400 WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO ADDITIONAL COILS NEEDED. THERE WAS NO ALLEGED DEFICIENCY WITH THE PX SLIM. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848419 ↗
• InjuryJun 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, AFTER DELIVERING FOUR PC400 COILS IN THE TARGET VESSEL, IT WAS NOTICED THAT A PC400 LOOP WAS PROLAPSING IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). NO FLOW OR THROMBOEMBOLIC PROBLEMS WERE OBSERVED; HOWEVER, THE PROTRUDING PC400 LOOP WAS SECURED USING A STENT AND DUAL ANTIPLATELET THERAPY (DAPT). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5763025 ↗
• MalfunctionMar 11, 2016Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO REACH THE TARGET VESSEL AND DELIVER THE PC400 COILS, THEREFORE, THE PHYSICIAN DEPLOYED AND DETACHED TWO PC400 COILS INTO A BRANCH VESSEL LOCATED BEFORE THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). NEXT, THE PHYSICIAN DEPLOYED A THIRD PC400 COIL INTO THE BRANCH VESSEL; HOWEVER, THE PC400 COIL WAS UNABLE TO DETACH USING THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW HANDLE TO DETACH THE PC400 COIL BUT WAS STILL UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PC400 COIL FROM THE PATIENT. WHILE THE PC400 COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 COIL FROM THE PATIENT AND ENDED THE PROCEDURE AT THIS POINT SINCE ANGIOGRAPHY REVEALED OCCLUSION OF THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5496473 ↗