Smart Coil 400SMTSTD1045Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548014401), received between Mar 7, 2018 and Oct 2, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE IMPLANTED INTO THE TARGET VESSEL FOLLOWED BY ONE NON-PENUMBRA COIL, AND ONE SMART COIL. THE NEXT SMART COIL WAS UNABLE TO MOVE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. WHILE MANIPULATING THE SMART COIL ON THE BACK TABLE POST-PROCEDURE, THE PHYSICIAN WAS ABLE TO ADVANCE THE COIL BEFORE KINKING THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL SMART COILS, FIFTY-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 12566449 ↗
• MalfunctionApr 22, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, NON-PENUMBRA SHEATH, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE FIRST SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, TWO NEW SMART COILS WERE PLACED AND DETACHED IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AN ATTEMPT WAS MADE TO MANUALLY DETACH THE PUSHER ASSEMBLY OF THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710346 ↗
• MalfunctionMar 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE SMART COILS INTO THE TARGET LOCATION BEFORE REMOVING THE MICROCATHETER AND FLUSHING IT ON THE BACK TABLE. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE SMART COIL AND THE MICROCATHETER WERE REMOVED AND FLUSHED ON THE BACK TABLE. NEXT, THE SAME SMART COIL WAS RE-ADVANCED THROUGH THE MICROCATHETER AND THE SAME ISSUE OCCURRED; THEREFORE, THE SMART COIL WAS REMOVED AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE OTHER 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

  MAUDE report 11570850 ↗
• MalfunctionJun 9, 2020Failure 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) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT FULLY ADVANCE INTO THE TARGET VESSEL; THEREFORE, THE SMART COIL WAS RE-SHEATHED. THE PHYSICIAN THEN REPOSITIONED THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE SAME SMART COIL; HOWEVER, THE COIL WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, THE SMART COIL 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 10136076 ↗
• MalfunctionOct 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, 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 9195041 ↗
• InjuryDec 7, 2018Premature Separation; Premature Separation

  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 THE FIRST COIL, A SMART COIL, INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER THAT WAS JAILED WITH A STENT AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK). HOWEVER, AFTER TWO THIRDS OF THE SMART COIL WAS ADVANCED INTO THE ANEURYSM, THE CATHETER BEGAN TO KICK BACK OUT OF THE ANEURYSM. IT WAS REPORTED THAT FURTHER ATTEMPTS TO ADVANCE THE MICROCATHETER AND SMART COIL WERE UNSUCCESSFUL. WHEN ATTEMPTING TO RETRACT BOTH THE SMART COIL AND CATHETER, THE PHYSICIAN FELT RESISTANCE AND THE SMART COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ADVANCED MULTIPLE SNARE DEVICES THROUGH THE BENCHMARK TO BREAK THE SMART COIL AND WAS ABLE TO RETRACT THE BENCHMARK WITH PART OF THE SMART COIL AND THE SNARES OUT OF THE PATIENT. THE PHYSICIAN STENTED THE OTHER PART OF THE SMART COIL TO THE CERVICAL PORTION OF THE CAROTID ARTERY, AND THE PROCEDURE WAS COMPLETED USING A NEW BENCHMARK, NEW MICROCATHETER, AND NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144598 ↗
• MalfunctionSep 28, 2018Difficult or Delayed Positioning; Physical Resistance/Sticking; Difficult or Delayed Positioning; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NON-PENUMBRA MICROCATHETER INTO THE TARGET LOCATION AND ATTEMPTED TO PLACE A SMART COIL, HOWEVER, THE PHYSICIAN REPEATEDLY ADVANCED AND RETRACTED THE SMART COIL TO REPOSITION IT. CONSEQUENTLY, THE PHYSICIAN BEGAN TO EXPERIENCE RESISTANCE WHILE ADVANCING NEAR THE DISTAL TIP OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THIS THEN OCCURRED WITH A SECOND SMART COIL. THE PHYSICIAN THEN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET LOCATION, HOWEVER, WAS UNABLE TO DETACH THE COIL USING THE HANDLE. IT WAS REPORTED THAT THERE WAS AN ABNORMAL SOUND WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH THE HANDLE. THE PHYSICIAN THEREFORE USED A SECOND HANDLE TO DETACH THE SMART COIL. THE PROCEDURE WAS THEN COMPLETED USING THE SECOND HANDLE AND ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918948 ↗
• MalfunctionAug 30, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY CALCIFIED AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL AND ANOTHER COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER THE SAME RESISTANCE WAS FELT. IT WAS REPORTED THAT THE PUSHER ASSEMBLIES OF THE SMART COILS WERE SLIGHTLY KINKED. THE PROCEDURE WAS THEREFORE COMPLETED USING NEW 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 7835728 ↗
• MalfunctionAug 30, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY CALCIFIED AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL AND ANOTHER COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER THE SAME RESISTANCE WAS FELT. IT WAS REPORTED THAT THE PUSHER ASSEMBLIES OF THE SMART COILS WERE SLIGHTLY KINKED. THE PROCEDURE WAS THEREFORE COMPLETED USING NEW 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 7835202 ↗
• MalfunctionApr 4, 2018Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) (C3) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN GRADUALLY EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK AT THE TIP OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7397926 ↗
• InjuryMar 7, 2018Break; Detachment Of Device Component; Retraction Problem; Break; Detachment Of Device Component; Retraction Problem

  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 ADVANCED A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND THEN ATTEMPTED TO RETRACT THE SMART COIL TO REPOSITION IT. HOWEVER, WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL UNINTENTIONALLY DETACHED WITH PART OF IT STILL WITHIN THE TARGET ANEURYSM. THE SMART COIL SUBSEQUENTLY BROKE INTO MULTIPLE PIECES; THEREFORE, THE PHYSICIAN USED A STENT RETRIEVER TO REMOVE THE BROKEN SMART COIL DURING MULTIPLE ATTEMPTS. 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 7320902 ↗