Smart Coil 400SMTXSFT2H08Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548015576), received between Nov 9, 2016 and Oct 26, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING A NEW HANDLE, BUT THE SMART COIL WOULD STILL NOT DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED WITH THE MAJORITY OF THE SMART COIL IN THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN USED A GUIDEWIRE TO SUCCESSFULLY PUSH THE REMAINING PART OF THE DETACHED SMART COIL INTO THE ANEURYSM. AFTERWARDS, THE FOLLOWING SMART COIL, WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS 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 15671758 ↗
• MalfunctionOct 10, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPINAL ARTERY USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT, BUT THE SMART COIL WOULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN PULLED ON THE TAB WITH MEDICAL CLAMPS AND SUCCESSFULLY DETACHED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602662 ↗
• MalfunctionOct 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE NEXT SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. SUBSEQUENTLY, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602385 ↗
• MalfunctionOct 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WAS INSERTED INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. AFTER REMOVING THE SMART COIL AND TESTING IT ON THE BACK TABLE, BUT THE COIL WOULD STILL NOT ADVANCE PAST THE INITIAL POSITION. THE SMART COIL WAS PULLED OUT OF ITS INTRODUCER SHEATH AND PLACED INTO SALINE. NEXT, THE PHYSICIAN CUT OFF THE PROXIMAL END OF THE INTRODUCER SHEATH AND THEN RELOADED THE SMART COIL INTO THE INTRODUCER SHEATH AND SUBSEQUENTLY SUCCESSFULLY IMPLANTED THE SMART COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601665 ↗
• MalfunctionAug 11, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER . DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE THE NEXT TWO SMART COILS INTO A NEW MICROCATHETER, THE SMART COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310683 ↗
• MalfunctionJul 14, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK AT THE HUB OF THE MICROCATHETER AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS ALSO REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12164716 ↗
• MalfunctionApr 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT UNSHEATH WHEN ENTERING THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 11649497 ↗
• MalfunctionJan 9, 2021Failure to Advance; Failure to Advance

  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. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11144083 ↗
• MalfunctionApr 16, 2020Material Frayed; Failure to Advance; Material Frayed; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE BACK END OF THE SMART COIL HAD FRAYED OFF. 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 9968462 ↗
• MalfunctionMay 2, 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 EXPERIENCED DIFFICULTY ADVANCING TWO SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE MICROCATHETER, AND, THEREFORE, THE SMART COILS WERE REMOVED. 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 7481220 ↗
• InjuryNov 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COIL) TO TREAT AN ANEURYSM THAT HAD FORMED OFF AN ANEURYSM CLIPPING DONE ON THE PATIENT YEARS PRIOR. DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER'S INTRACRANIAL SUPPORT CATHETER, BALLOON CATHETER, AND MICROCATHETER, THEN ADVANCED A SMART COIL THROUGH THE OTHER MANUFACTURER'S MICROCATHETER. WHILE ATTEMPTING TO POSITION THE SMART COIL IN THE ANEURYSM, THE PHYSICIAN FELT THAT THE MICROCATHETER AND SMART COIL ¿JUMPED¿ AS THE SECOND LOOP OF THE SMART COIL WAS OUT OF THE MICROCATHETER. CONSEQUENTLY, THE ANEURYSM WAS PERFORATED BY THE MICROCATHETER AND SMART COIL. THE PHYSICIAN USED THE SMART COIL TO FILL THE RUPTURED ANEURYSM. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND TWO ADDITIONAL SMART COILS. AN EXTERNAL VENTRICULAR DRAIN WAS PLACED AT THE END OF THE PROCEDURE. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED CONTINUOUS FLUSH IN THE PROCEDURE. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) PREFORMED ON (B)(6) 2016 DEMONSTRATED SUBARACHNOID HEMORRHAGE (SAH) AND A SMALL VOLUME INTRAPENCHYMAL

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 6091393 ↗