Smart Coil 400SMTXSFT2H03Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548015316), received between May 25, 2018 and Nov 22, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE NEXT SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO PRESS THE TRIGGER OF THE HANDLE HALFWAY WHILE PULLING ON THE PUSHER ASSEMBLY, BUT THE SMART COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN USED FORCEPS TO MANUALLY DETACH THE SMART COIL. SUBSEQUENTLY, THE NEXT TWO SMART COILS WOULD NOT DETACH USING A NEW HANDLE. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO PRESS THE TRIGGER OF THE HANDLE HALFWAY WHILE PULLING ON THEIR RESPECTIVE PUSHER ASSEMBLY, BUT THE SMART COILS DID NOT DETACH. THE PHYSICIAN ALSO ATTEMPTED TO USE FORCEPS TO MANUALLY DETACH THE SMART COILS BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856811 ↗
• MalfunctionNov 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS, NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVERAL PENUMBRA AND NON-PENUMBRA COILS INTO THE ANEURYSM. NEXT, WHILE ATTEMPTING TO ADVANCE THE SMART COIL, IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE SMART COILS WERE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12755922 ↗
• MalfunctionDec 28, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL PAST THE FRICTION LOCK 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11082628 ↗
• MalfunctionOct 20, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO SMART COILS THROUGH THE MICROCATHETER AND, THEREFORE, BOTH SMART COILS WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN THEN EXCHANGED FOR A NEW MICROCATHETER AND ATTEMPTED TO ADVANCE THE SAME SMART COILS; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, BOTH SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 10708839 ↗
• MalfunctionOct 20, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO SMART COILS THROUGH THE MICROCATHETER AND, THEREFORE, BOTH SMART COILS WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN THEN EXCHANGED FOR A NEW MICROCATHETER AND ATTEMPTED TO ADVANCE THE SAME SMART COILS; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, BOTH SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 10708837 ↗
• MalfunctionNov 25, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WAS ADVANCED TO THE TARGET LOCATION. THE PHYSICIAN THEN RETRACTED AND ADVANCED THE SMART COIL APPROXIMATELY 2-3 TIMES UNTIL THE COIL TOOK ITS INTENDED SHAPE. NEXT, THE PHYSICIAN DETACHED THE SMART COIL USING THE HANDLE. HOWEVER, WHEN THE PUSHER ASSEMBLY OF THE SMART COIL WAS PULLED, THE PHYSICIAN NOTICED THE SMART COIL WAS RETRACTED A FEW CENTIMETERS WITH THE PUSHER ASSEMBLY AND DID NOT DETACH. THE SMART COIL WAS THEN RE-ADVANCED INTO THE TARGET VESSEL AND THE PHYSICIAN MADE ANOTHER ATTEMPT TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL STILL DID NOT DETACH; THEREFORE, THE PHYSICIAN DECIDED TO BREAK THE PROXIMAL END OF THE PUSHER ASSEMBLY TO MANUALLY DETACH THE SMART COIL. AFTER A FEW ATTEMPTS, THE SMART COIL DETACHED AND WAS IMPLANTED INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372518 ↗
• MalfunctionSep 10, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN RESUMED THE PROCEDURE AND SUCCESSFULLY PLACED ANOTHER RUBY COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A SMART COIL WHICH ¿WOULD NOT COIL;¿ THEREFORE, IT WAS REMOVED. THE PHYSICIAN RESUMED THE PROCEDURE AGAIN AND SUCCESSFULLY PLACED ANOTHER SMART COIL. THE PROCEDURE WAS CONTINUED AND COMPLETED USING PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984788 ↗
• MalfunctionMay 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO FLUSH THE PENUMBRA SMART COIL (SMART COIL) WITHIN ITS INTRODUCER SHEATH; HOWEVER, THE FLUID WAS NOT DRIPPING OUT OF THE END OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PENUMBRA SMART COIL DETACHMENT HANDLE WAS NOT USED BECAUSE THE SMART COIL WAS NEVER INSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8569377 ↗
• InjuryMay 25, 2018Physical Resistance; Physical Resistance

  ON (B)(6) 2018 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 DEPLOYED AND DETACHED TWO SMART COILS USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO DEPLOY A THIRD SMART COIL THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SMART COIL, AND THE ANEURYSM RUPTURED AS A SMART COIL WAS BEING PLACED. THEREFORE, THE PATIENT WAS IMMEDIATELY ADMINISTERED 15 MG OF PROTAMINE. THE SMART COIL WAS SUCCESSFULLY IMPLANTED, AND THE RUPTURED ANEURYSM WAS SUCCESSFULLY TREATED BY IMPLANTING ADDITIONAL SMART COILS. AFTER THE PROCEDURE, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY SCAN (CT SCAN). THE CT SCAN SHOWED SUBARACHNOID CONTRAST EXTRAVASATION. THE PATIENT WAS SOMNOLENT, LETHARGIC, HAD A TOP OF HEAD HEADACHE, LEFT PERIORAL DROOP, AND WAS CONFUSED ON (B)(6) 2018. CHRONIC LEFT HEMIPARESIS WAS UNCHANGED. A CT SCAN ON (B)(6) 2018 SHOWED INTERVAL IMPROVEMENT OF THE SUBARACHNOID HEMORRHAGE. ON (B)(6) 2018, THE PATIENT WAS ALERT AND ORIENTED. ON (B)(6) 2018, THE SUBJECT WAS ALERT AND ORIENTED BUT COMPLAINED OF HEADACHE, NECK STIFFNESS, AND SOME GENERALIZ

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 7545762 ↗