Smart Coil 400SMTSFT0720Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548014739), received between Mar 20, 2020 and Sep 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. 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.

• MalfunctionSep 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE NINE NON-PENUMBRA COILS AND TWO SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL IN THE MICROCATHETER HUB, RESISTANCE WAS ENCOUNTERED AND THE COIL BECAME STUCK. SEVERAL ATTEMPTS WERE MADE TO IMPLANT THE SMART COIL WITHOUT SUCCESS; THEREFORE, THE SMART COIL AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING SIX RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530937 ↗
• MalfunctionMar 20, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL APPROXIMATELY 15 CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. IT WAS NOTED THAT SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE SMART COIL FURTHER, BUT RESISTANCE WAS ENCOUNTERED AT THE SAME LOCATION; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE NON-PENUMBRA 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 9861136 ↗