Smart Coil 400SMTHXSFT0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548015774), received between Mar 10, 2017 and Jun 15, 2021 — classified as 2 injuries, 6 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 18, 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.

• MalfunctionJun 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ADVANCE THE SMART COIL BY NOT HOLDING THE INTRODUCER SHEATH AT THE FRICTION LOCK; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS; THEREFORE, THE SMART COILS WERE ALSO 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 12005723 ↗
• MalfunctionDec 16, 2020Failure to Advance; 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 PUSH PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. 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 11024075 ↗
• MalfunctionSep 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SMART COIL BECAME STUCK. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE SMART COIL BACK INTO ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE SMART COIL, AND THEN REMOVED THE SMART COIL. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER COILS, AND ANOTHER MICROCATHETER. 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 10556567 ↗
• MalfunctionJan 11, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO SMART COILS WITHIN THEIR INTRODUCER SHEATHS AND; THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW 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 8242302 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) TO TREAT AN UNRUPTURED ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD THREE SMART COILS THROUGH THE HUB OF TWO DIFFERENT NON-PENUMBRA MICROCATHETERS, THE PHYSICIAN EXPERIENCED FRICTION. THE SMART COILS WERE ABLE TO BE ADVANCED TO THE DISTAL TIP OF THE THEIR INTRODUCER SHEATHS BUT WOULD NOT ADVANCE COMPLETELY OUT OF THE SHEATHS AND INTO THE MICROCATHETERS. THEREFORE, THE SMART COILS WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO NEW SMART COILS, ADDITIONAL COILS AND THE SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242809 ↗
• InjuryDec 29, 2017Fracture; Mechanical Problem; Retraction Problem; Fracture; Mechanical Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO IMPLANT THE LAST SMART COIL, IT WAS REPORTED THAT THE SMART COIL FELT STICKY WITHIN THE NON-PENUMBRA MICROCATHETER, AND CONSEQUENTLY, THE SMART COIL REMAINED PARTIALLY WITHIN THE TIP OF THE MICROCATHETER, CAUSING A SMALL 1 CM COIL TAIL PROLAPSE INTO THE PARENT VESSEL WHEN THE SMART COIL WAS DETACHED. ADDITIONALLY, THE SMART COIL PUSHER ASSEMBLY FRACTURED AND WAS STUCK WITHIN THE ROTATING HEMOSTASIS VALVE(RHV) AS THE PHYSICIAN RETRACTED THE PUSHER WIRE AFTER PLACING THE SMART COIL. THE PROCEDURE ENDED AT THIS POINT AND THE PUSHER WIRE WAS REMOVED AS THE PHYSICIAN REMOVED THE MICROCATHETER. THE PHYSICIAN ADMINISTERED AN UNKNOWN MEDICATION AND PLACED THE PATIENT ON ASPIRIN. IT WAS ADJUDICATED THAT THE COIL TAIL PROLAPSE WAS A NON-SERIOUS DEVICE-RELATED ADVERSE EVENT THAT WAS UNRELATED TO THE DISEASE STATE, AND HAD A PROBABLE RELATIONSHIP TO BOTH THE PROCEDURE AND THE SMART COIL SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155134 ↗
• MalfunctionMay 1, 2017Device Operates Differently Than Expected; Difficult to Advance; Device Operates Differently Than Expected; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A SMART COIL IN THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER; THE SMART COIL WOULD NOT COMPLETELY ADVANCE INTO THE ANEURYSM CAUSING THE MICROCATHETER TO BE ¿KICKED OUT¿ THE ANEURYSM. 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 Consequences Or Impact To Patient

  MAUDE report 6535474 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). THERE WAS NO REPORT OF A DEVICE MALFUNCTION WITH THE SMART COILS. SEVEN DAYS AFTER THE PROCEDURE, THE PATIENT HAD A STROKE AND WAS TREATED WITH ATIVAN. THE REPORTED STROKE WAS BELIEVED TO BE POSSIBLY RELATED TO THE SMART COIL SYSTEM. ON (B)(6) 2017, THE PATIENT SUFFERED ANOTHER POSSIBLE STROKE AND WAS ADMITTED TO THE HOSPITAL. AS OF 02/092017, IT IS UNKNOWN WHAT THE PATIENT'S CONDITION IS. PLEASE NOTE THAT THE MANUFACTURER HAS REQUESTED FURTHER INFORMATION FROM THE STUDY SITE; HOWEVER, AS OF 03/07/2017, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ischemia; Neurological Deficit/Dysfunction

  MAUDE report 6395953 ↗