Smart Coil 400SMTSFT0610Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814548014968), received between Nov 16, 2016 and Dec 31, 2021 — classified as 2 injuries, 12 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2021Separation Failure; Unintended Movement; Migration; Difficult or Delayed Separation; Separation Failure; Unintended Movement; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THEN, THE PHYSICIAN ADVANCED THREE SMART COILS (F106492, F106751, AND F106751) TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THEM USING A HANDLE; HOWEVER, THE SMART COILS FAILED TO DETACH. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS USING A SECOND HANDLE; HOWEVER, THEY WERE UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COILS USING A HEMOSTAT; HOWEVER, IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COILS WERE REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT SMART COIL (F86218) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. HOWEVER, UPON RETRACTING THE MICROCATHETER FROM THE ANEURYSM, THE SMART COIL CAME OUT OF THE ANEURYSM. THEREFORE, THE PHYSICIAN ADVANCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13130516 ↗
• 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 12701016 ↗
• MalfunctionMay 3, 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) AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE ANY FURTHER; THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766179 ↗
• MalfunctionNov 6, 2020Failure 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). DURING THE PROCEDURE, A SMART COIL BECAME STUCK IN THE INTRODUCER SHEATH AND WAS UNABLE TO ADVANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 10805454 ↗
• MalfunctionJul 22, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS. DURING THE PROCEDURE, A LOOP OF FIRST SMART COIL WAS PUSHED BACK INTO THE ARTERY DURING THE PLACEMENT OF SECOND SMART COIL. THE PROCEDURE WAS COMPLETED USING FOUR MORE SMART COILS. POST-PROCEDURE, THE PATIENT WAS DOSED WITH BRILINTA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311736 ↗
• MalfunctionJun 17, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A SMART COIL; HOWEVER, NOTICED THAT THE COIL WAS "DEFORMED". THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING SIX NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703981 ↗
• MalfunctionMar 28, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH, DESPITE MULTIPLE 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 8459469 ↗
• MalfunctionApr 25, 2018Contamination; Device Damaged Prior to Use; Device Handling Problem; Contamination; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PENUMBRA SMART COIL (SMART COIL) AND THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) WERE CONTAMINATED BY A NON-STERILE HAND. THE SMART COIL AND HANDLE WERE CONTAMINATED PRIOR TO USE AND THEREFORE, WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7463133 ↗
• MalfunctionDec 11, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE PET LOCK ON THE PUSHER ASSEMBLY WAS SEPARATED; HOWEVER, WHILE ATTEMPTING TO REMOVE THE COIL PUSHER ASSEMBLY, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT DETACHED. AT THIS TIME, THE SMART COIL WAS ALREADY PULLED OUT OF THE ANEURYSM AND THEREFORE, WAS RE-ADVANCED INTO THE ANEURYSM WITHOUT ISSUE. THE PHYSICIAN THEN PINNED THE SMART COIL PUSHER ASSEMBLY THEN PULLED THE PULL WIRE AND MANUALLY DETACHED AND PLACED THE SMART COIL IN THE ANEURYSM. IT WAS ALSO REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL USING THE SAME HANDLE; THEREFORE, THE SMART COIL WAS MANUALLY DETACHED AS WELL. THE PROCEDURE WAS COMPLETED WITH A TOTAL SEVEN SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106424 ↗
• MalfunctionNov 17, 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 WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS 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 7043285 ↗
• MalfunctionOct 30, 2017Material Too Rigid or Stiff; Device Operates Differently Than Expected; Material Too Rigid or Stiff; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER AND INTO THE TARGET LOCATION, HOWEVER, WHILE ADVANCING THE LAST THIRD OF THE SMART COIL INTO THE ANEURYSM, THE SMART COIL STRAIGHTENED OUT AND WOULD NOT FORM LOOPS, CAUSING THE MICROCATHETER TO BACK OUT OF THE ANEURYSM. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A SECOND SMART COIL, HOWEVER, THE SAME ISSUE OCCURRED AND THE LAST THIRD OF THE SMART COIL STIFFENED UP, CAUSING THE MICROCATHETER TO BACK OUT OF THE ANEURYSM. WITH EFFORT, THE PHYSICIAN WAS ABLE TO FULLY ADVANCE THE SMART COIL AND SUCCESSFULLY DETACHED IT WITHIN THE TARGET LOCATION. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6989090 ↗
• InjuryAug 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID TERMINUS USING PENUMBRA SMART COILS (SMART COILS). AFTER THE PROCEDURE, A FOLLOW-UP ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THROMBUS FORMATION AND SUBSEQUENT OCCLUSION; THEREFORE, INTRA-ARTERIAL INTEGRILIN WAS ADMINISTERED TO RESOLVE THE OCCLUSION. THE THROMBUS FORMATION WAS ADJUDICATED BY THE PHYSICIAN TO HAVE A DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Thrombosis; Thrombus

  MAUDE report 6795527 ↗
• InjuryMay 17, 2017Difficult or Delayed Activation; Malposition of Device; Difficult or Delayed Activation; Malposition of Device

  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 DEPLOYED AN INITIAL SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. AFTER DETACHING THE SMART COIL, THE PHYSICIAN NOTICED THAT A VERY STIFF TAIL WAS PRESENT INSIDE THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PUSH IT OUT OF THE MICROCATHETER WITH THE SECOND SMART COIL THINKING THAT IT WAS JUST THE TAIL; HOWEVER, UPON PUSHING THE TAIL OF THE SMART COIL OUT OF THE MICROCATHETER WITH THE SECOND COIL, THE INITIAL SMART COIL SHOT BACK INTO THE PARENT VESSEL. THE PHYSICIAN DID NOT MAKE ANY ATTEMPTS TO REMOVE THE INITIAL COIL SINCE IT WAS ALREADY DETACHED. CONSEQUENTLY, THE PATIENT ENDED UP HAVING A LARGE STROKE DUE TO THE SMART COIL THAT WAS LEFT IN THE PARENT VESSEL. IT IS UNKNOWN IF THE PHYSICIAN DID ANYTHING TO TREAT THE STROKE. AS OF (B)(6) 2017, THE PATIENT IS STILL IN THE HOSPITAL.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 6572786 ↗
• MalfunctionNov 16, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RADIOLOGIC TECHNOLOGIST INADVERTENTLY KINKED THE PENUMBRA SMART COIL (SMART COIL) PUSHER ASSEMBLY UPON REMOVAL OF THE COIL FROM ITS DISPENSER HOOP. THE SMART COIL PUSHER ASSEMBLY BECAME KINKED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW SMART COIL AND ANOTHER MANUFACTURER'S COILS. IT SHOULD BE NOTED THAT THE PHYSICIAN ONLY WANTED TO TRY THE SMART COIL AS A FRAMING COIL AND DID NOT INTEND TO USE SMART COILS FOR THE ENTIRE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6107662 ↗