Smart Coil 400SMTSTD1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548014395), received between Jun 4, 2018 and Dec 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL (HANDLE). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED THE FIRST THREE SMART COILS IN THE TARGET VESSEL AFTER MAKING MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. WHILE ATTEMPTING TO PLACE FOURTH SMART COIL, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING A NEW HANDLE TO DETACH THE SAME FOURTH SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453867 ↗
• MalfunctionJun 4, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE DISTAL TIP OF THE SMART COIL CURLED INSIDE THE HUB OF THE MICROCATHETER AND WOULD NOT ADVANCE INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER 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 7567650 ↗