Smart Coil 400SMTXSFT0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814548015163), received between Jul 13, 2017 and Oct 4, 2021 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT CERVICAL MENINGIOMA USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL AND MADE MULTIPLE ATTEMPTS TO DETACH THE SMART COIL USING THE FIRST HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. A SECOND HANDLE WAS THEN USED BUT HAD THE SAME ISSUE; SUBSEQUENTLY, THE PHYSICIAN MADE SEVERAL ATTEMPTS TO MANUALLY DETACH THE SMART COIL BUT IT STILL WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS RETRACTED. HOWEVER, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INTO THE DISTAL OF THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE SMART COIL WITH THE PUSHER WIRE INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS, THE SAME BENCHMARK 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 12572757 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT DETACH WITH THE HANDLE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939628 ↗
• MalfunctionApr 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR CEREBELLUM VESSEL USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA NON-PENUMBRA SHEATH, NON-PENUMBRA CATHETER, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, ONE SMART COIL WAS SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE A SECOND SMART COIL INTO THE TARGET VESSEL, THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) WAS UNABLE TO DETACH IT. THE PHYSICIAN THEN DECIDED TO REMOVE SMART COIL. HOWEVER, WHILE RETRACTING, THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN INJECTED SALINE THROUGH THE MICROCATHETER TO PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM. WHILE ATTEMPTING TO PLACE A THIRD SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THE SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749768 ↗
• MalfunctionDec 13, 2020Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION; HOWEVER, DECIDED TO REPOSITION THE SMART COIL. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE SMART COIL BACK INTO THE ANEURYSM. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE MICROCATHETER. THEN, TO TEST THE SMART COIL THE PHYSICIAN ADVANCED AND RETRACTED THE SMART COIL SEVERAL TIMES IN THE PROXIMAL END OF THE MICROCATHETER AND THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE SMART COIL. SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE SMART COIL BACK INTO THE ANEURYSM. 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; No Consequences Or Impact To Patient

  MAUDE report 10999086 ↗
• MalfunctionOct 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COILS), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE LAST SMART COIL AND REPORTED THAT IT WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, THE SAME BENCHMARK, 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 10617477 ↗
• MalfunctionJul 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE SMART COIL STOPPED ADVANCING FURTHER. THE PHYSICIAN THEN RETRACTED THE SMART COIL BACK INTO ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH; HOWEVER, THE SMART COIL WOULD NOT ADVANCE FORWARD. THEREFORE, THE SMART COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN PLACED TWO SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL OUT OF ITS INTRODUCER SHEATH; THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. 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 10348045 ↗
• MalfunctionNov 26, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. 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 9378357 ↗
• InjuryJan 11, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THE DISTAL END OF THE SMART COIL WAS PULLED BACK INTO THE MICROCATHETER AND WAS RE-ADVANCED INTO THE ANEURYSM. THE PHYSICIAN THEN MADE A SECOND ATTEMPT, BUT THE SMART COIL DID NOT DETACH. IT WAS REPORTED THAT THE SMART COIL PET LOCK WAS SEPARATED. THE SMART COIL THEN UNINTENTIONALLY DETACHED WHILE BEING RE-ADVANCED INTO THE ANEURYSM, BUT BEFORE REACHING OPTIMAL POSITION. THE TAIL OF THE SMART COIL DID NOT HANG INTO THE BASILAR ARTERY BUT IN THE ANEURYSM NECK. SOME THROMBUS FORMATION WAS OBSERVED DUE TO ADDITIONAL COIL REPOSITIONING; HOWEVER, AFTER LYSIS AND WAITING, THE THROMBUS DISAPPEARED AND SHOWED A GOOD FINAL RESULT. THE PROCEDURE WAS ENDED AT THIS POINT AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Thrombosis

  MAUDE report 8242310 ↗
• MalfunctionJul 24, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND A HANDLE. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL IN THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW IT; HOWEVER, AS THE PHYSICIAN WAS PULLING THE SMART COIL BACK, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED A WIRE TO SUCCESSFULLY PUSH THE DETACHED COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, THE SAME HANDLE AND ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716133 ↗
• MalfunctionJul 20, 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 SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE HUB OF 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 7707992 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. COMPLETION OF THE RIGHT CAROTID CEREBRAL ANGIOGRAM INITIALLY DEMONSTRATED A SMALL AMOUNT OF THROMBUS LOCATED AT THE DISTAL NECK OF THE AZYGOS PERICALLOSAL ANEURYSM WITHIN THE AZYGOS PERICALLOSAL ARTERY; HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, THE THROMBUS WAS RESOLVED. THERE WAS NO REMEDIAL THERAPY, MEDICAL PROCEDURE OR HOSPITALIZATION REQUIRED TO ADDRESS THE THROMBUS FORMATION. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY, (B)(6) 2018. THE THROMBUS FORMATION WAS REPORTED TO HAVE A DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM AND UNRELATED TO THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7622723 ↗
• MalfunctionNov 8, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL OUT ITS INTRODUCER SHEATH AND INTO THE HUB OF A NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY 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 7009866 ↗
• MalfunctionJul 19, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ACUTE RUPTURED BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER. AFTER SEVERAL FAILED ATTEMPTS TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH, THE INTRODUCER SHEATH CONTAINING THE SMART COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SMART COIL AND ADDITIONAL COILS WITHOUT ANY ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6725103 ↗
• MalfunctionJul 13, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO ADVANCE THREE SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO A NON-PENUMBRA MICROCATHETER. THEREFORE, THE INTRODUCER SHEATHS CONTAINING THE SMART COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. IT WAS REPORTED THAT IT WAS DIFFICULT TO PUSH SOME OF THE COILS OUT OF THEIR INTRODUCER SHEATHS ON THE BACK TABLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712433 ↗