Smart Coil 400SMTHXSFT1H01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814548015637), received between Nov 25, 2019 and Mar 11, 2021 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMar 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464389 ↗
• MalfunctionAug 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE, THE PATIENT¿S VESSEL WAS PERFORATED USING A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO USE PENUMBRA SMART COILS (SMART COILS) TO STOP THE BLEEDING; HOWEVER, SIX SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE NEXT THREE SMART COILS WERE IMPLANTED IN THE TARGET LOCATION USING THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL USING THE HANDLE, IT WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS; THEREFORE, THIS SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING FIVE SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10354066 ↗
• MalfunctionAug 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE, THE PATIENT¿S VESSEL WAS PERFORATED USING A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO USE PENUMBRA SMART COILS (SMART COILS) TO STOP THE BLEEDING; HOWEVER, SIX SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE NEXT THREE SMART COILS WERE IMPLANTED IN THE TARGET LOCATION USING THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL USING THE HANDLE, IT WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS; THEREFORE, THIS SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING FIVE SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10354061 ↗
• MalfunctionMay 19, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) 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 10072208 ↗
• MalfunctionDec 26, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA 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 9522032 ↗
• MalfunctionNov 25, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN OPENED ANOTHER SMART COIL, AND IT 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 9373278 ↗