Smart Coil 400SMTSFT0930Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548014784), received between Jun 5, 2020 and Mar 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A RECOILING EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) USING A SMART COIL (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AN INTERMEDIATE CATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE TARGET VESSEL WAS PREVIOUSLY COILED USING STENT SUPPORT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE ADDITIONAL ATTEMPTS TO DETACH THE SMART COIL USING A SECOND HANDLE AND VIA MANUAL DETACHMENT; HOWEVER, THE SMART COIL WOULD STILL NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. WHILE REMOVING THE SMART COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530948 ↗
• MalfunctionNov 18, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A WIDE NECK MIDDLE CEREBRAL ARTERY ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA BIFURCATION ANEURYSM IMPLANT DEVICE. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BIFURCATION ANEURYSM IMPLANT DEVICE INTO THE ANEURYSM USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE TWO ADDITIONAL ATTEMPTS; HOWEVER, THE SMART COIL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON REMOVAL, THE SMART COIL UNINTENTIONALLY DETACHED WITH APPROXIMATELY THE LAST THREE CENTIMETERS OF THE SMART COIL IN THE MICROCATHETER. THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE DETACHED SMART COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, THE SAME HANDLE, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833996 ↗
• MalfunctionOct 1, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AFTER MULTIPLE ATTEMPTS WERE MADE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL; THEREFORE, THE SMART COIL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12565758 ↗
• MalfunctionSep 9, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL, THE SMART COIL BECAME STUCK IN THE MICROCATHETER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449823 ↗
• MalfunctionJun 23, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN REMOVED THE HANDLE AND TRIED USING TWO NEW HANDLES TO DETACH THE SAME SMART COIL, BUT THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW SMART COIL INTO THE ANEURYSM USING THE FIRST HANDLE. AFTERWARDS, A NEW SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054017 ↗
• MalfunctionJun 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE ABOUT HALFWAY INTO THE MICROCATHETER, AND THE SMART COIL WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11915186 ↗
• MalfunctionJun 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS FISTULA (PAVF) USING A 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 ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123185 ↗