Smart Coil 400SMTHXSFT0415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548015842), received between Feb 7, 2019 and Jan 27, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RT CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL COULD NOT BE DETACHED USING THE HANDLE. THEN, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY BREAKING THE PUSHER ASSEMBLY; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. SALINE WAS THEN USED TO PUSH THE SMART COIL TO THE TARGET LOCATION. THE SAME ISSUE OCCURRED WITH ADDITIONAL THREE SMART COILS. ALL THREE DETACHED SMART COILS WERE IMPLANTED IN THE CAVERNOUS SINUS BY USING SALINE. THE PROCEDURE WAS COMPLETED USING THIRTY-ONE NON-PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367464 ↗
• MalfunctionDec 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930041 ↗
• MalfunctionJun 3, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) VIA THE RIGHT OCCIPITAL VEIN USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TEN NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, PHYSICIAN DECIDED TO REMOVE THE SMART COIL. SUBSEQUENTLY, WHILE ATTEMPTING TO REMOVE THE SMART COIL, THE PHYSICIAN NOTICED THAT THE SMART COIL WAS ENTWINED WITH THE NON-PENUMBRA COILS THAT WERE PREVIOUSLY PLACED. CONSEQUENTLY, THE PHYSICIAN WAS UNABLE TO REMOVE THE SMART COIL. AFTERWARDS, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930841 ↗
• MalfunctionMar 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATH. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441104 ↗
• MalfunctionDec 2, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE PLACED IN THE TARGET VESSEL USING THE NON-PENUMBRA MICROCATHETER; HOWEVER, IT WAS REPORTED THAT THE FRICTION LOCK FOR ALL THREE SMART COILS WERE NOT WORKING AND THE SMART COILS WERE LOOSE WITHIN THE INTRODUCER SHEATH. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE PUSHER ASSEMBLY, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED SMART COIL INTO THE ANEURYSM USING THE PUSHER ASSEMBLY AND IMPLANTED THE COIL. SUBSEQUENTLY, ANOTHER SMART COIL WAS ADVANCED INTO THE VESSEL AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL AND HANDLE WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO A BOWL OF SALINE ON THE BACK TABLE; HOWEVER, THE SMART COIL WOULD NOT ADVANCE PAST THE FRI

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10931832 ↗
• MalfunctionDec 2, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE PLACED IN THE TARGET VESSEL USING THE NON-PENUMBRA MICROCATHETER; HOWEVER, IT WAS REPORTED THAT THE FRICTION LOCK FOR ALL THREE SMART COILS WERE NOT WORKING AND THE SMART COILS WERE LOOSE WITHIN THE INTRODUCER SHEATH. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE PUSHER ASSEMBLY, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED SMART COIL INTO THE ANEURYSM USING THE PUSHER ASSEMBLY AND IMPLANTED THE COIL. SUBSEQUENTLY, ANOTHER SMART COIL WAS ADVANCED INTO THE VESSEL AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL AND HANDLE WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO A BOWL OF SALINE ON THE BACK TABLE; HOWEVER, THE SMART COIL WOULD NOT ADVANCE PAST THE FRI

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10931801 ↗
• MalfunctionDec 16, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A SMART COILS INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN INSERTED A NEW SMART COIL INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475255 ↗
• MalfunctionFeb 7, 2019Retraction Problem; Retraction Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF ADVANCED A PENUMBRA SMART COIL (SMART COIL) INTO A BOWL OF SALINE ON THE BACK TABLE. HOWEVER, THE HOSPITAL STAFF WAS UNABLE TO RE-SHEATH THE SMART COIL AND THEREFORE THE SMART COIL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8315116 ↗