Smart Coil 400SMTSFT0506Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548015149), received between Mar 14, 2018 and Jan 6, 2023 — classified as 2 injuries, 8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Premature 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. 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 ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL WOULD STILL NOT DETACH. SUBSEQUENTLY, AFTER MANY UNSUCCESSFUL ATTEMPTS TO DETACH THE SMART COIL, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE GENTLY RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE PHYSICIAN ALSO USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113810 ↗
• 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 12701111 ↗
• MalfunctionSep 28, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ADVANCING THE TWO SMART COILS, THEY BECAME STUCK WITHIN THE FRICTION LOCKS. THEREFORE, THE SMART COILS WERE REMOVED. IT WAS REPORTED MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE SMART COILS, INCLUDING DIFFERENT HAND PLACEMENTS, BUT THE ATTEMPTS WERE UNSUCCESSFUL. 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 12541126 ↗
• InjuryJul 29, 2021Break; Difficult or Delayed Separation; Break; Difficult or Delayed Separation

  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 BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT AND ANOTHER NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT IN THE TARGET VESSEL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SMART COIL TO FRAME THE TARGET LOCATION, BUT EXPERIENCED RESISTANCE AND ALSO FELT THAT THE COIL WAS STIFF. THE COIL COMPARTMENTALIZED WHILE FRAMING; HOWEVER, THE PHYSICIAN WAS ABLE TO FRAME IT AFTER RETRACTING AND ADVANCING IT BACK INTO THE ANEURYSM. THE PHYSICIAN THEN DETACHED THE SMART COIL USING THE HANDLE AND PULLED THE PUSHER WIRE BACK AFTER NOTICING THE DETACHMENT MARKERS TO BE SEPARATED. UNDER FLUOROSCOPY, IT WAS NOTICED THAT THE SMART COIL WAS NOT ACTUALLY DETACHED AND WAS STRETCHED. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE STENT, AND THEREFORE, ATTEMPTED TO REMOVE THE STENT ALONG WITH THE SMART COIL, BUT THE SMART COIL CONTINUED TO STRETCH EVEN AFTER THE STENT WAS REMOVED FROM THE PATIENT. SUBSEQUENTLY, THE PHYSICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246451 ↗
• MalfunctionJul 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097643 ↗
• MalfunctionMar 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. AFTER MAKING MULTIPLE ATTEMPTS, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, RUBY COIL LPS, AND PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464608 ↗
• MalfunctionJan 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE INTRODUCER SHEATH OF THE FIRST SMART COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND HUB OF THE MICROCATHETER. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO ADVANCE THE SMART COIL, INCLUDING MOVING THEIR FINGERS TO THE SIDE OF THE FRICTION LOCK. HOWEVER, THE SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION. 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; No Consequences Or Impact To Patient

  MAUDE report 11219557 ↗
• MalfunctionDec 2, 2020Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), NON-PENUMBRA CATHETER, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER FLUSHING THE INTRODUCER SHEATHS OF TWO SMART COILS, THE PHYSICIAN WAS ABLE TO ADVANCE THE SMART COILS FROM THEIR STARTING POSITIONS WITHIN THE INTRODUCER SHEATHS BUT NEEDED A LOT OF PRESSURE. THEREFORE, THE PHYSICIAN REMOVED THE SMART COILS. THE PROCEDURE WAS COMPLETED USING NEW 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 10931844 ↗
• MalfunctionNov 25, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-MICROCATHETER BETWEEN TWO STENT DEVICES INTO THE TARGET VESSEL AND PLACED A NON-PENUMBRA COIL. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO TARGET VESSEL AND DETACHED IT USING THE HANDLE. HOWEVER, WHEN THE PUSHER ASSEMBLY OF THE SMART COIL WAS PULLED, THE PHYSICIAN NOTICED THE SMART COIL WAS RETRACTED A FEW CENTIMETERS WITH THE PUSHER ASSEMBLY. THEREFORE, THE SMART COIL WAS RE-ADVANCED INTO THE TARGET VESSEL AND AN ATTEMPT WAS MADE TO DETACH IT BY PULLING THE TRIGGER OF THE HANDLE. HOWEVER, AFTER PULLING THE PUSHER ASSEMBLY OF THE SMART COIL, THE SMART COIL WAS RETRACTED AGAIN AND DETACHED A FEW CENTIMETERS INTO THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE REMAINING SMART COIL INTO TARGET VESSEL. IT WAS ALSO REPORTED THAT RESISTANCE WAS MET WHILE ATTEMPTING TO ADVANCE THREE OTHER COILS THROUGH THE MICROCATHETER AND THE COILS WOULD NOT ADVANCE. THEREFORE, THE MICROCATHETER WAS REMOVED AND UPON FLUSHING SALINE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371609 ↗
• InjuryMar 14, 2018Adverse 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 RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE SMART COIL AND A NON-PENUMBRA STENT. DURING THE PROCEDURE THERE WAS THROMBUS FORMATION, AND THEREFORE THE HOSPITAL STAFF IMMEDIATELY ADMINISTERED THROMBOLYTICS INTRA-ARTERIALLY. THERE WAS COMPLETE RESTORATION OF FLOW, AND THE PATIENT DEMONSTRATED NO NEW RESIDUAL NEUROLOGIC DEFICITS FROM THIS EVENT. THIS ADVERSE EVENT WAS RESOLVED. THE THROMBUS FORMATION WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Thrombus

  MAUDE report 7339852 ↗