Smart Coil 400SMTHXSFT0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548015811), received between Oct 30, 2017 and Oct 26, 2021 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW 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 12701077 ↗
• MalfunctionSep 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SOME SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, TWO SMART COILS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO SMART COILS WERE 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 12457571 ↗
• MalfunctionMay 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. 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 11795116 ↗
• MalfunctionApr 23, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND TWO NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE FIRST SMART COIL WOULD NOT DETACH AFTER MULTIPLE ATTEMPTS WERE MADE WITH THREE HANDLES. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WAS STUCK IN THE FIRST MICROCATHETER. THE SMART COIL WAS THEN REMOVED. SUBSEQUENTLY, THE PHYSICIAN USED A SECOND SMART COIL, THE THIRD HANDLE, AND THE SAME MICROCATHETER. HOWEVER, THE PHYSICIAN WAS ALSO UNABLE TO DETACH THE SMART COIL WITH THE HANDLE AFTER MULTIPLE ATTEMPTS WERE MADE. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WAS STUCK IN THE MICROCATHETER. THE SMART COIL AND MICROCATHETER WERE THEN REMOVED. THE PHYSICIAN RESUMED THE PROCEDURE AND SUCCESSFULLY PLACED THE THIRD SMART COIL WITH THE HANDLE AND SECOND MICROCATHETER. NEXT, THE PHYSICIAN USED A FOURTH SMART COIL, THE SAME HANDLE, AND THE SAME SECOND MICROCATHETER. HOWEVER, THE PHYSICIAN WAS ALSO UNABLE TO DETACH THE SMART COIL WITH THE HANDLE AFTER MULTIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716632 ↗
• MalfunctionMar 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATH. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441017 ↗
• MalfunctionSep 4, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE SMART COILS SEPARATELY INTO THE AVM AND CLICKED ON THE HANDLE. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED TO A SECOND HANDLE AFTER EXPERIENCING THIS ISSUE WITH TWO TO THREE SMART COILS; HOWEVER, THE SECOND HANDLE FAILED TO DETACH THE REMAINING SMART COILS. THE PUSHER ASSEMBLY OF EACH SMART COIL INDICATED THE SMART COIL WAS DETACHED CORRECTLY, BUT BOTH HANDLE FAILED TO DETACH FIVE SMART COILS. THEREFORE, THE SMART COILS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10496935 ↗
• MalfunctionAug 15, 2019Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  DURING RECEIVING INSPECTION OF A PENUMBRA SMART COIL (SMART COIL), THE SMART COIL PRODUCT DISPLAY BOX WAS FOUND TO HAVE SUSTAINED DAMAGE WHILE IN TRANSIT. HOWEVER, THE PHYSICIAN PROCEEDED TO USE THE SMART COIL IN THE PROCEDURE. DURING ADVANCEMENT OF THE SMART COIL THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE SMART COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896809 ↗
• MalfunctionJan 17, 2018Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED INITIAL COILS AND SMART COILS INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN DEPLOYED AND DETACHED A NEW SMART COIL WITHOUT ANY MENTION OF RESISTANCE. SUBSEQUENTLY, WHILE THE PHYSICIAN WAS RETRACTING THE SMART COIL PUSHER ASSEMBLY, THE TIP OF THE PUSHER ASSEMBLY BROKE OFF IN THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE DETACHED PIECE OF THE PUSHER ASSEMBLY WAS PULLED OUT OF THE RHV AND THE PROCEDURE WAS COMPLETED USING THE SAME RHV, MICROCATHETER, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202374 ↗
• MalfunctionOct 30, 2017Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO BIG FOR THE ANEURYSM AND DECIDED TO PULL IT BACK; HOWEVER, WHILE RETRACTING THE SMART COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. WITHOUT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER. HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN REALIZED THAT THE PREVIOUS SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE NEW SMART COIL WAS REMOVED INTACT. THE MICROCATHETER CONTAINING THE DETACHED COIL WAS THEN REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN THEN DETERMINED THAT THE SMART COIL THAT WAS PREVIOUSLY REMOVED INTACT WAS THE WRONG SIZE PRIOR TO REINSERTING IT INTO THE MICROCATHETER AND CONTINUED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988755 ↗