Smart Coil 400SMTHXSFT2H08Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548016016), received between Mar 16, 2017 and Jun 16, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPINAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, 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 THEN WAS ABLE TO DETACH THE SMART COIL AFTER MAKING ANOTHER ATTEMPT. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL WOULD STILL NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN IMPLANTED APPROXIMATELY FOUR TO FIVE NON-PENUMBRA COILS ON TOP OF THE DETACHED SMART COIL TO KEEP IT IN PLACE. THE PHYSICIAN THEN ADVANCED A THIRD SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713785 ↗
• MalfunctionSep 16, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL HANDLES (HANDLES). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT DETACH USING TWO HANDLES. IT WAS REPORTED THAT THE HANDLES CREATED SMALL SEPARATION OF THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE SMART COILS PUSHER ASSEMBLIES BUT THE SMART COILS WOULD NOT DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COILS IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A THIRD HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484939 ↗
• MalfunctionMay 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED; THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766442 ↗
• MalfunctionNov 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUPERIOR HYPOPHYSEAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE BENCHMARK IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE HUB OF THE BENCHMARK WAS CRACKED, AND AIR WAS STARTING TO COME THROUGH THE CRACK; THEREFORE, THE BENCHMARK WAS REMOVED. ANOTHER BENCHMARK WAS THEN USED TO CONTINUE THE PROCEDURE. NEXT, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE INTO THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, THE SECOND BENCHMARK, 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 9287512 ↗
• MalfunctionFeb 22, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, AND THEREFORE THE SMART COIL 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 7290874 ↗
• MalfunctionDec 14, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, ADDITIONAL 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 7119524 ↗
• MalfunctionSep 6, 2017Material Frayed; Retraction Problem; Stretched; Physical Resistance; Material Frayed; Retraction Problem; Stretched; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER BUT DECIDED TO REMOVE THE COIL AND USE A SMALLER SIZED COIL. WHILE RETRACTING THE SMART COIL BACK THROUGH MICROCATHETER, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE SMART COIL WAS FRAYED AND SLIGHTLY STRETCHED. THEREFORE, THE PROCEDURE WAS COMPLETED USING NEW SMART 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 6846816 ↗
• MalfunctionMay 3, 2017Break; Physical Resistance; Material Integrity Problem; Break; Physical Resistance; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A FOURTH SMART COIL, THE PHYSICIAN FELT RESISTANCE AND DECIDED TO REMOVE THE COIL. UPON INSPECTION AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE COIL FILAMENT WAS BROKEN MID-COIL. THE COIL WAS STILL INTACT BUT WAS NOT USABLE. THEREFORE, THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART 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 6541976 ↗
• MalfunctionMar 16, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PUSHING A SMART COIL THROUGH ITS INTRODUCER SHEATH. CONSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6412053 ↗