Smart Coil 400SMTXSFT011HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00814548015170), received between Jan 11, 2017 and Sep 29, 2023 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A MICROWAVE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET LOCATION SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. WHILE RETRACTING

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17844127 ↗
• InjurySep 29, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A MICROWAVE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET LOCATION SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. WHILE RETRACTING

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17844126 ↗
• MalfunctionJun 3, 2022Difficult 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 COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED ONE SMART COIL IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO MANUALLY DETACH THE SMART COIL USING A HEMOSTAT, BUT THE COIL WOULD STILL NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A NEW SMART COIL INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUED OCCURRED AND THE PHYSICIAN WAS UNABLE TO MANUALLY DETACH THE SMART COIL USING A HEMOSTAT. SUBSEQUENTLY, WHEN THE PUSHER ASSEMBLY OF THE SMART COIL WAS RETRACTED, THE PHYSICIAN NOTICED THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN INSERTED A NEW SMART COIL INTO THE MICROCATHETER AND USED IT TO PUSH THE DETACH SMART COIL INTO THE ANEURYSM AND IMPLANTED BOTH SMART COILS. THE PROCEDURE HAD END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599010 ↗
• MalfunctionNov 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT MIDDLE MENINGEAL ARTERY (MMA) BLEED USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE INTRODUCER SHEATH OF A SMART COIL INTO A ROTATING HEMOSTASIS VALVE (RHV) AND ATTEMPTED TO ADVANCE THE SMART COIL. HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840794 ↗
• MalfunctionApr 30, 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 COIL), NON-PENUMBRA COIL, PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL AND ANOTHER COIL IN THE TARGET VESSEL USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE SMART COIL. HOWEVER, WHILE RETRACTING, THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. A GUIDEWIRE WAS THEN USED TO PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752937 ↗
• MalfunctionApr 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH A SECOND SMART COIL; THEREFORE, IT WAS ALSO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11722080 ↗
• InjuryFeb 20, 2020Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERIES (PCOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL TO THE ANEURYSM OF THE TARGET VESSEL. THE SMART COIL WAS THEN DETACHED USING THE HANDLE, AND IT WAS INITIALLY THOUGHT TO HAVE BEEN COMPLETELY DETACHED. HOWEVER, AS THE PUSHER ASSEMBLY OF THE SMART COIL WAS BEING RETRACTED, THE SMART COIL WAS PULLED OUT OF THE ANEURYSM, UNINTENTIONALLY DETACHED, AND WENT DOWNSTREAM. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SMART COIL USING A STENT RETRIEVER BUT WAS UNSUCCESSFUL. THE SMART COIL WAS THEN LEFT IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA). THE PROCEDURE ENDED AT THIS POINT, AND NO COILS WERE PLACED IN THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735336 ↗
• MalfunctionOct 7, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE 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 9164150 ↗
• MalfunctionAug 13, 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, 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 8888882 ↗
• MalfunctionJun 14, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (RMCA) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING A SMART COIL THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND PAST THE HUB OF THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS WITH THE SAME RHV AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699661 ↗
• MalfunctionMay 7, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SMART COIL PUSHER ASSEMBLY BECAME KINKED PRIOR TO INSERTING INTO THE ROTATING HEMOSTASIS VALVE (RHV); THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS 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 8588431 ↗
• MalfunctionJan 4, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT ANTERIOR DESCENDING (LAD) PSEUDOANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN WAS THEN ABLE TO ADVANCE THE SMART COIL OUTSIDE OF ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE SMART COIL INTO THE MICROCATHETER; HOWEVER, IT WOULD NOT ADVANCE. THE SMART COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 8219456 ↗
• MalfunctionNov 17, 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 THROUGH ITS INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS 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 8082068 ↗
• MalfunctionJul 11, 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 FOUR SMART COILS INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE SMART COILS WERE REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679262 ↗
• MalfunctionApr 4, 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 A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE 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 7395551 ↗
• MalfunctionNov 3, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL SMART COILS INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE SMART COIL WAS REMOVED AND 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 7000273 ↗
• MalfunctionOct 18, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING A SMART COIL HALF WAY THROUGH A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 6959784 ↗
• MalfunctionJan 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATION ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE TWO SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE NON-PENUMBRA MICROCATHETER, THEREFORE BOTH SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND 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 6244374 ↗