Smart Coil 400SMTSTD1860Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548014340), received between Mar 14, 2018 and Apr 22, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, NON-PENUMBRA SHEATH, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE FIRST SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, TWO NEW SMART COILS WERE PLACED AND DETACHED IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AN ATTEMPT WAS MADE TO MANUALLY DETACH THE PUSHER ASSEMBLY OF THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710269 ↗
• MalfunctionJan 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER. AS THE SMART COIL BEGAN TO EMERGE FROM THE MICROCATHETER, IT BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL 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 9629081 ↗
• MalfunctionJul 3, 2019Failure to Fold; Material Deformation; Failure to Fold; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE NIDUS OF MALFORMATION USING A NON-PENUMBRA MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT FORM DUE TO THE HIGH FLOW. THEREFORE, THE SMART COIL WAS RETRACTED AND SAVED FOR LATER USE. NEXT, THE PHYSICIAN PLACED TWO OTHER COILS IN THE TARGET VESSEL AND ATTEMPTED TO LOAD THE SAME SMART COIL INTO THE MICROCATHETER AGAIN; HOWEVER, THE SMART COIL WAS INADVERTENTLY KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 8758324 ↗
• MalfunctionApr 18, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FROM THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT A TYPE II ENDOLEAK USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY 10 TO 15 CENTIMETERS INTO THE NON-PENUMBRA MICROCATHETER. CONSEQUENTLY, THE SMART COIL BECAME STUCK INSIDE OF THE INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529887 ↗
• MalfunctionMar 14, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED COILS IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A SMART COIL INTO THE TARGET LOCATION; HOWEVER, THE SMART COIL WAS ABLE TO BE SUCCESSFULLY DEPLOYED AND DETACHED. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER. CONSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY BECAME KINKED IN MULTIPLE LOCATIONS, CAUSING THE SMART COIL TO UNINTENTIONALLY DETACH WHILE PARTIALLY WITHIN THE ANEURYSM AND PARTIALLY OUTSIDE THE ANEURYSM. THE LOOP OF THE DETACHED SMART COIL THAT WAS OUTSIDE OF THE ANEURYSM WAS PINNED TO THE VESSEL WALL BY A NON-PENUMBRA STENT, AND THEREFORE NO ATTEMPTS WERE MADE TO REMOVE THE DETACHED SMART COIL FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338542 ↗