Smart Coil 400SMTHXSFT0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548015835), received between Oct 30, 2017 and Oct 18, 2021 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 03-NOV-2021 INDICATED THAT THE ISCHEMIC STROKE WAS ADJUDICATED BY THE CLINICAL INVESTIGATOR TO BE UNRELATED TO THE SMART COILS AND RELATED TO THE INDEX PROCEDURE.

  Patient problems: Ischemia Stroke

  MAUDE report 12651347 ↗
• MalfunctionSep 16, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL HANDLES (HANDLES). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT DETACH USING TWO HANDLES. IT WAS REPORTED THAT THE HANDLES CREATED SMALL SEPARATION OF THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE SMART COILS PUSHER ASSEMBLIES BUT THE SMART COILS WOULD NOT DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COILS IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A THIRD HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484935 ↗
• MalfunctionJul 13, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. HOWEVER, THE SMART COIL WAS LATER SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT A FINAL ANGIOGRAPHY SHOWED OCCLUSION OF THE SIGMOID SINUS. 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 12160446 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS; THEREFORE, THE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698460 ↗
• MalfunctionJul 22, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATHS. SUBSEQUENTLY, THE SMART COILS WERE REMOVED. THE HOSPITAL STAFF THEN ATTEMPTED TO ADVANCE THE SMART COILS OUT OF THE INTRODUCER SHEATHS ON THE BACK TABLE, AND THE SMART COILS WERE FOUND STUCK IN THE INITIAL POSITION. THEREFORE, THE SMART COILS WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312040 ↗
• MalfunctionApr 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE SMART COIL OUT OF ITS INTRODUCER SHEATH AND THEN ATTEMPTED TO RE-INSERT THE SMART COIL INTO ITS INTRODUCER SHEATH BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9973387 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE BEYOND ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, IT WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864371 ↗
• MalfunctionMar 26, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A SMART COIL INTO THE NON-PENUMBRA MICROCATHETER; HOWEVER, THE COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THE SMART COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451255 ↗
• MalfunctionJan 25, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL THROUGH ITS INTRODUCER SHEATH, BUT IT WOULD NOT ENTER INTO THE HUB OF THE MICROCATHETER. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. A SECOND SMART COIL WAS THEN ADVANCED THROUGH ITS INTRODUCER SHEATH BUT THE SAME ISSUE OCCURRED. THE SECOND SMART COIL WAS ALSO REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 8279001 ↗
• MalfunctionOct 12, 2018Failure 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 SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE COILS SEEMED TO GET STUCK IN THE HUB OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7963202 ↗
• MalfunctionOct 12, 2018Failure 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 SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE COILS SEEMED TO GET STUCK IN THE HUB OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7963184 ↗
• MalfunctionAug 13, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (A-COMM) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH ANOTHER SMART COIL USING THE HANDLE; THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL THROUGH THE MICROCATHETER; HOWEVER, WHILE RETRACTING TO RE-POSITION THE SMART COIL WITHIN THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED SMART COIL FROM THE PATIENT. LATER IN THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX SMART COILS, OTHER 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 7779302 ↗
• MalfunctionMay 25, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE STRAIGHT SINUS VEIN USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN TRIED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE, HOWEVER WAS UNABLE TO MOVE THE SMART COIL. THE PROCEDURE WAS THEREFORE 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 7545378 ↗
• MalfunctionMar 2, 2018Bent; Failure to Advance; Physical Resistance; Bent; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD A SMART COIL INTO A NON-PENUMBRA MICROCATHETER THROUGH THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE OUT ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE SMART COIL PUSHER ASSEMBLY BECAME BENT FROM TRYING TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW SMART COIL 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 7310424 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) TO TREAT AN UNRUPTURED ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD THREE SMART COILS THROUGH THE HUB OF TWO DIFFERENT NON-PENUMBRA MICROCATHETERS, THE PHYSICIAN EXPERIENCED FRICTION. THE SMART COILS WERE ABLE TO BE ADVANCED TO THE DISTAL TIP OF THE THEIR INTRODUCER SHEATHS BUT WOULD NOT ADVANCE COMPLETELY OUT OF THE SHEATHS AND INTO THE MICROCATHETERS. THEREFORE, THE SMART COILS WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO NEW SMART COILS, ADDITIONAL COILS AND THE SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242806 ↗
• MalfunctionOct 30, 2017Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO BIG FOR THE ANEURYSM AND DECIDED TO PULL IT BACK; HOWEVER, WHILE RETRACTING THE SMART COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. WITHOUT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER. HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN REALIZED THAT THE PREVIOUS SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE NEW SMART COIL WAS REMOVED INTACT. THE MICROCATHETER CONTAINING THE DETACHED COIL WAS THEN REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN THEN DETERMINED THAT THE SMART COIL THAT WAS PREVIOUSLY REMOVED INTACT WAS THE WRONG SIZE PRIOR TO REINSERTING IT INTO THE MICROCATHETER AND CONTINUED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988751 ↗