Smart Coil 400SMTXSFT0205Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814548015293), received between Apr 7, 2016 and Jun 20, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 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 HOSPITAL STAFF WAS UNABLE TO PUSH THREE SMART COILS OUT OF THE 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 7621654 ↗
• MalfunctionJun 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 HOSPITAL STAFF WAS UNABLE TO PUSH THREE SMART COILS OUT OF THE 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 7621415 ↗
• MalfunctionJun 11, 2018Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE THE PHYSICIAN SUCCESSFULLY PLACED A COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, WILE REMOVING THE SMART COIL PUSHER ASSEMBLY, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER REMOVING APPROXIMATELY HALF OF THE SMART COIL PUSHER ASSEMBLY. SUBSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND SMART COIL PUSHER ASSEMBLY TOGETHER, AND COMPLETED THE PROCEDURE USING ANOTHER MICROCATHETER 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 7587756 ↗
• MalfunctionNov 2, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL; HOWEVER, UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE DETACHED SMART COIL WAS THEN SUCCESSFULLY PUSHED INTO THE ANEURYSM. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998000 ↗
• MalfunctionJun 13, 2017Difficult to Insert; Difficult to Insert

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO INSERT TWO SMART COILS INTO THE UNKNOWN MICROCATHETER. THEREFORE, THE INTRODUCER SHEATHS CONTAINING BOTH SMART COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING SIXTEEN OTHER SMART COILS AND THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6636865 ↗
• MalfunctionApr 7, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS INTO THE PATIENT. THE PHYSICIAN THEN INSERTED A FOURTH SMART COIL INTO THE PATIENT; HOWEVER, THE COIL WAS NOT IMPLANTED AND WAS REMOVED BECAUSE THE MICROCATHETER KICKED OUT OF THE ANEURYSM. THE PROCEDURE WAS COMPLETED AT THIS POINT. DURING A ROUTINE FOLLOW UP VISIT, THE ANGIOGRAPHY REVEALED THAT AT LEAST TWO OF THE THREE IMPLANTED SMART COILS WERE HERNIATING OUT OF THE ANEURYSM NECK AND INTO THE PARENT VESSEL. THE PHYSICIAN DID NOT PERFORM ANY INTERVENTION BECAUSE THE PATIENT WAS ALREADY ON AN ANTICOAGULANT REGIMEN OF ASPIRIN AND ELIQUIS. THE PATIENT WAS STABLE AND ASYMPTOMATIC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5556218 ↗