Smart Coil 400SMTSTD1245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548014432), received between Oct 9, 2018 and Oct 2, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR 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 THEN ATTEMPTED TO ADVANCE TWO OTHER SMART COILS; HOWEVER, THE SAME ISSUE OCCURRED, AND THEREFORE, THEY WERE REMOVED. 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 9148304 ↗
• MalfunctionOct 9, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO SMART COILS WITHIN THEIR INTRODUCER SHEATHS AND, THEREFORE, THE SMART COILS WERE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED MULTIPLE NON-PENUMBRA COILS USING THE SAME NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL FULLY OUT OF THE TIP OF THE MICROCATHETER. THE SMART COIL WAS THEREFORE REMOVED, AND THE PHYSICIAN SUCCESSFULLY PLACED A DIFFERENT COIL. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER, THE PHYSICIAN AGAIN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL FULLY OUT OF THE TIP OF THE MICROCATHETER. THE SMART COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW 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 7950100 ↗