Smart Coil 400SMTSTD0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548014593), received between Dec 22, 2016 and Oct 18, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH, THE 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 ADDITIONAL SMART COILS. ON (B)(6) 2021, THE PATIENT SUFFERED SEVERAL MINI EMBOLIC SUBACUTE BIHEMISPHERIC INFARCTIONS. THE PATIENT WAS STARTED ON 100 MG OF ACETYLSALICYLIC ACID DAILY. ON (B)(6) 2021, INFORMATION WAS RECEIVED INDICATING THAT THE EVENT WAS RESOLVED ON (B)(6) 2021. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ON (B)(6) 2021 THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WITH SLIGHT PSYCHOMOTOR SLOWDOWN WITHOUT FOCAL NEUROLOGIC SIGNS AND PAIN COMPENSATION. THE SEVERAL MINI EMBOLIC SUBACUTE BIHEMISPHERIC INFARCTIONS WERE REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12652642 ↗
• MalfunctionOct 16, 2021Stretched; Difficult or Delayed Separation; Stretched; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE TWO OTHER ATTEMPTS, BUT THE SMART COIL WOULD NOT DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT IT WAS UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE SMART COIL USING MEDICAL PLIERS, BUT THE SMART COIL DID NOT DETACH. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT THE PUSHER ASSEMBLY KEPT STRETCHING BUT THE SMART COIL DID NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTING APPROXIMATELY THREE CENTIMETERS OF THE SMART COIL INTO THE MICROCATHETER, THE SMART COIL DETACHED. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY OF THE SMART COIL AND THEN USED THE GUIDEWIRE TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE TARGET LOCATION. THE PROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643845 ↗
• MalfunctionMar 29, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, ALL THREE SMART COILS WERE REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11581496 ↗
• MalfunctionJan 29, 2021Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. 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 SEVERAL ADDITIONAL ATTEMPTS; HOWEVER, THE SMART COIL DID NOT DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, APPROXIMATELY AFTER ONE THIRD OF THE SMART COIL WAS RETRACTED INTO THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN PUSHED THE SMART COIL USING ITS PUSHER ASSEMBLY AND A NON-PENUMBRA GUIDEWIRE INTO THE ANEURYSM. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE SEVERAL ADDITIONAL

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

  MAUDE report 11255306 ↗
• MalfunctionDec 27, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AFTER SEVERAL ATTEMPTS; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 9526138 ↗
• MalfunctionJul 20, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL FROM ITS INITIAL POSITION WITHIN THE 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 7707669 ↗
• MalfunctionJun 28, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CAROTID ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE THROUGH A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646579 ↗
• MalfunctionDec 22, 2016Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN FRAMED THE ANEURYSM WITH ANOTHER MANUFACTURER¿S COIL BEFORE ATTEMPTING TO DEPLOY A SMART COIL TO HELP FILL THE ANEURYSM;. HOWEVER, WHILE DEPLOYING THE SMART COIL THROUGH A NON PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE MICROCATHETER KICKED OUT THE ANEURYSM; THEREFORE, THE SMART COIL WAS REMOVED AND RE-SHEATHED. THEREAFTER, THE PHYSICIAN RE-ACCESSED THE ANEURYSM WITH A WIRE INSIDE THE MICROCATHETER AND SUCCESSFULLY DEPLOYED AND DETACHED A NEW SMART COIL IN THE ANEURYSM WITHOUT ISSUE. THEE 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 6198784 ↗