Smart Coil 400SMTSTD1660Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548014326), received between Jan 18, 2018 and Apr 3, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE (0.014). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ADVANCED THE 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 DETACH THE SMART COIL MANUALLY AND BY USING A HEMOSTAT BUT WAS STILL UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED HALFWAY IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE AND PUSHED THE COIL BACK INTO THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL MANUALLY BUT THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668386 ↗
• MalfunctionSep 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAXILLARY ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WERE UNABLE TO ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE 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 12509552 ↗
• MalfunctionJun 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL SUCCESSFULLY. THE PHYSICIAN THEN RETRACTED THE FIRST SMART COIL FROM ITS INTRODUCER SHEATH AND USED THE INTRODUCER SHEATH FROM THE SECOND SMART COIL. THE PHYSICIAN WAS ABLE TO ADVANCE THE SMART COIL INTO THE MICROCATHETER SUCCESSFULLY WITHOUT RESISTANCE. 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

  MAUDE report 11919097 ↗
• MalfunctionFeb 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 11334993 ↗
• MalfunctionJan 20, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND NON-PENUMBRA MICROCATHETERS. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS MODERATELY TORTUOUS, AND THERE WERE TWO LOOPS IN THE ACCESS VESSEL. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A COIL IN THE TARGET VESSEL WITH THE FIRST MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN INSERTED THE INTRODUCER SHEATH OF A SMART COIL INTO A NEW MICROCATHETER. THE SMART COIL WAS STUCK AT THE INITIAL POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER, FOLLOWED BY 12 RUBY COILS, 10 NON-PENUMBRA COILS, AND A NON-PENUMBRA 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 11205084 ↗
• MalfunctionJan 10, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATHS AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, BOTH SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8236621 ↗
• MalfunctionDec 5, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN IATROGENIC PSEUDOANEURYSM OF THE RIGHT FEMORAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A COIL AND A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136106 ↗
• MalfunctionMar 14, 2018Detachment Of Device Component; Kinked; Physical Resistance; Detachment Of Device Component; Kinked; Physical Resistance

  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 SUCCESSFULLY PLACED COILS IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A SMART COIL INTO THE TARGET LOCATION; HOWEVER, THE SMART COIL WAS ABLE TO BE SUCCESSFULLY DEPLOYED AND DETACHED. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER. CONSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY BECAME KINKED IN MULTIPLE LOCATIONS, CAUSING THE SMART COIL TO UNINTENTIONALLY DETACH WHILE PARTIALLY WITHIN THE ANEURYSM AND PARTIALLY OUTSIDE THE ANEURYSM. THE LOOP OF THE DETACHED SMART COIL THAT WAS OUTSIDE OF THE ANEURYSM WAS PINNED TO THE VESSEL WALL BY A NON-PENUMBRA STENT, AND THEREFORE NO ATTEMPTS WERE MADE TO REMOVE THE DETACHED SMART COIL FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338536 ↗
• MalfunctionJan 18, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL AND AN ADDITIONAL COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL OUT OF THE TIP OF THE LANTERN, AND THEREFORE THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW SMART COILS, ADDITIONAL COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204450 ↗