Smart Coil 400SMTHXSFT0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548015859), received between Oct 26, 2017 and Jul 7, 2022 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED TWO SMART COILS IN THE TARGET VESSEL USING THE HANDLE. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. WHILE RETRACTING THE SMART COIL TO REMOVE IT, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED, AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING 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 14951428 ↗
• MalfunctionOct 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701083 ↗
• MalfunctionSep 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WERE UNABLE TO ADVANCE AT ALL FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523564 ↗
• MalfunctionJul 1, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE SMART COIL TO BE REMOVED. SUBSEQUENTLY, UPON PLACING THE SMART COIL ON THE BACK TABLE, THE SMART COIL HAD DETACHED FROM THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104117 ↗
• MalfunctionJun 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE 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. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ADVANCE THE SMART COIL BY NOT HOLDING THE INTRODUCER SHEATH AT THE FRICTION LOCK; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS; THEREFORE, THE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL 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 12005726 ↗
• MalfunctionDec 24, 2020Failure 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) AND A NON-PENUMBRA MICROCATHETER (ECHELON). DURING THE PROCEDURE TWO SMART COILS WERE UNABLE TO ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11070923 ↗
• MalfunctionAug 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MANDIBULAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL INTO THE ROTATING HEMOSTATIC VALVE (RHV), THE FELLOW EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWENTY-SIX OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431457 ↗
• MalfunctionAug 14, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS, A PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE SMART COILS INTO THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO PULL THE BACK END OF THE DETACHMENT ZONE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO BREAK THE STAINLESS STEEL HYPOTUBE AND SUBSEQUENTLY, THE HYPOTUBE SNAPPED AND THERE WAS NO INNER NITINOL WIRE TO PULL ON. THEREFORE, THE SMART COIL WAS REMOVED. THEN, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW HANDLE TO DETACH THE SMART COIL; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411333 ↗
• 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 10312041 ↗
• MalfunctionMar 26, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEEDING ARTERY BRANCH USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE INTRODUCER SHEATH OF THE SMART COIL WAS PINCHED TOO TIGHT AND THE COIL WAS UNABLE TO ADVANCED OUT OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886102 ↗
• MalfunctionDec 23, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS UNABLE TO ADVANCE BEYOND ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511024 ↗
• MalfunctionAug 2, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DIVERTICULUM OF THE SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND DETACHED IT USING A HANDLE, HOWEVER, THE PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE AND, THEREFORE, BOTH THE HANDLE AND PUSHER ASSEMBLY WERE REMOVED. NEXT, THE PHYSICIAN MET RESISTANCE AND WAS UNABLE TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER; THEREFORE, THE SMART COIL WAS RE-SHEATHED AND SAVED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER NEW SMART COIL; HOWEVER, THE SAME RESISTANCE ISSUE OCCURRED, AND THE SMART COIL WAS ALSO RE-SHEATHED AND SAVED FOR LATER USE. IT WAS REPORTED THAT THE PHYSICIAN NOTICED A PIECE OF THE PUSHER ASSEMBLY WAS STUCK INSIDE OF THE MICROCATHETER, AND THEREFORE, A NON-PENUMBRA GUIDEWIRE WAS ADVANCED THROUGH THE MICROCATHETER TO PUSH ANY MATERIAL INTO THE DIVERTICULUM. THE PHYSICIAN THEN ADVANCED THE SAME SMART COILS THAT HAD BEEN RE-SHEATHED AND SAVED FOR LATER USE THROUGH THE SAME MICROCATHETER, AND SUCCESSFULLY DE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858020 ↗
• MalfunctionAug 2, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DIVERTICULUM OF THE SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND DETACHED IT USING A HANDLE, HOWEVER, THE PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE AND, THEREFORE, BOTH THE HANDLE AND PUSHER ASSEMBLY WERE REMOVED. NEXT, THE PHYSICIAN MET RESISTANCE AND WAS UNABLE TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER; THEREFORE, THE SMART COIL WAS RE-SHEATHED AND SAVED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER NEW SMART COIL; HOWEVER, THE SAME RESISTANCE ISSUE OCCURRED, AND THE SMART COIL WAS ALSO RE-SHEATHED AND SAVED FOR LATER USE. IT WAS REPORTED THAT THE PHYSICIAN NOTICED A PIECE OF THE PUSHER ASSEMBLY WAS STUCK INSIDE OF THE MICROCATHETER, AND THEREFORE, A NON-PENUMBRA GUIDEWIRE WAS ADVANCED THROUGH THE MICROCATHETER TO PUSH ANY MATERIAL INTO THE DIVERTICULUM. THE PHYSICIAN THEN ADVANCED THE SAME SMART COILS THAT HAD BEEN RE-SHEATHED AND SAVED FOR LATER USE THROUGH THE SAME MICROCATHETER, AND SUCCESSFULLY DE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858018 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING PENUMBRA SMART COILS (SMART COILS), THE TECHNICIAN WAS PREPARING THE SMART COIL ON THE BACK TABLE AND NOTED THAT THE SMART COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE SMART COIL WAS THEN DISCARDED AND THE PHYSICIAN COMPLETED THE CASE USING ANOTHER SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8711899 ↗
• MalfunctionMay 8, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591481 ↗
• MalfunctionNov 1, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL, HOWEVER, THE SMART COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028960 ↗
• MalfunctionJul 12, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS 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 7684060 ↗
• MalfunctionJan 5, 2018Failure 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 SUCCESSFULLY PLACED TWO COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE TWO SMART COILS INTO THE MICROCATHETER, AND THEREFORE THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169850 ↗
• MalfunctionOct 26, 2017Device Difficult to Setup or Prepare; Out-Of-Box Failure; Difficult to Open or Remove Packaging Material; Device Difficult to Setup or Prepare; Out-Of-Box Failure; Difficult to Open or Remove Packaging Material

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF WAS UNABLE TO REMOVE A PENUMBRA SMART COIL (SMART COIL) FROM ITS DISPENSER HOOP. THEREFORE, THE SMART COIL WAS SET ASIDE AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6979591 ↗