Smart Coil 400SMTHXSFT0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00814548015828), received between Jul 17, 2017 and Dec 21, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2021Difficult or Delayed Separation; Premature Separation; Difficult or Delayed 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 PLACED FIVE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE SIXTH SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT MULTIPLE TIMES USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, THE SAME HANDLE, 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 13056191 ↗
• MalfunctionOct 29, 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE FIRST SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH AFTER SEVERAL ATTEMPTS WERE MADE. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL FROM THE MICROCATHETER. THE SMART COIL WAS PLACED ON THE BACK TABLE AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE COIL; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN APPLIED FORCE TO PULL THE SMART COIL OUT OF THE INTRODUCER SHEATH AND PLACED THE COIL INTO SALINE. NEXT, THE PROXIMAL END OF THE INTRODUCER SHEATH WAS CUT OFF AND THE SMART COIL WAS RE-ADVANCED AND SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724172 ↗
• 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 12701015 ↗
• MalfunctionSep 16, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL HANDLES (HANDLES). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT DETACH USING TWO HANDLES. IT WAS REPORTED THAT THE HANDLES CREATED SMALL SEPARATION OF THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE SMART COILS PUSHER ASSEMBLIES BUT THE SMART COILS WOULD NOT DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COILS IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A THIRD HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484936 ↗
• 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 12005686 ↗
• MalfunctionJun 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. 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

  MAUDE report 11925731 ↗
• MalfunctionApr 26, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725199 ↗
• MalfunctionMar 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A SMART COIL AND REPORTED THAT IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS 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 11558424 ↗
• MalfunctionFeb 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA 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 11275704 ↗
• MalfunctionJul 3, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL FAILED TO DETACH USING THE HANDLE; THEREFORE, THE HANDLE AND SMART COIL WERE REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228165 ↗
• MalfunctionMay 28, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WAS UNABLE TO ADVANCE INTO THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 10098705 ↗
• MalfunctionFeb 27, 2020Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FACIAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE TECHNICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH AND SUBSEQUENTLY, THE PUSHER WIRE BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9760329 ↗
• MalfunctionOct 18, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE. AFTER MULTIPLE ATTEMPTS, THE SMART COIL FAILED TO DETACH ALTHOUGH IT WAS REPORTED THAT THE DETACHMENT MARKER WAS SEPARATED INTO TWO PARTS; THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS, ANOTHER HANDLE, 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 9208865 ↗
• MalfunctionAug 9, 2019Stretched; Failure to Advance; Physical Resistance/Sticking; Stretched; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE PAST THE DISTAL END OF THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE SMART COIL WAS OBSERVED TO BE STRETCHED UPON REMOVAL FROM THE INTRODUCER SHEATH OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879645 ↗
• MalfunctionMay 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THREE SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ONE OF THE SMART COILS OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE, BUT IT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THREE OTHER SMART COILS THROUGH THE MICROCATHETER; HOWEVER, THE SMART COILS WERE ABLE TO BE SUCCESSFULLY IMPLANTED INTO THE ANEURYSM. 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 Consequences Or Impact To Patient

  MAUDE report 8584605 ↗
• MalfunctionMay 1, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, AFTER ADVANCING THE SMART COIL APPROXIMATELY 10 CENTIMETERS PAST THE HUB OF A NON-PENUMBRA MICROCATHETER, THE SMART COIL AND PUSHER ASSEMBLY BECAME STUCK AND THE SMART COIL WAS UNABLE TO ADVANCE ANY FURTHER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SAME SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED AND THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW SMART COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568748 ↗
• MalfunctionJan 4, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE A NEW SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7165872 ↗
• MalfunctionDec 26, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. IT WAS ALSO REPORTED THAT THE HOSPITAL STAFF ATTEMPTED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH WHILE ON THE BACK TABLE BUT THE COIL DID NOT COME OUT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7146277 ↗
• MalfunctionOct 30, 2017Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO BIG FOR THE ANEURYSM AND DECIDED TO PULL IT BACK; HOWEVER, WHILE RETRACTING THE SMART COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. WITHOUT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER. HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN REALIZED THAT THE PREVIOUS SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE NEW SMART COIL WAS REMOVED INTACT. THE MICROCATHETER CONTAINING THE DETACHED COIL WAS THEN REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN THEN DETERMINED THAT THE SMART COIL THAT WAS PREVIOUSLY REMOVED INTACT WAS THE WRONG SIZE PRIOR TO REINSERTING IT INTO THE MICROCATHETER AND CONTINUED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988763 ↗
• MalfunctionJul 17, 2017Separation Failure; Device Operates Differently Than Expected; Separation Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLE (SCH1). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO DETACH A SMART COIL USING A SCH1 AND THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A BACKUP MECHANISM TO DETACH THE COIL. THE PROCEDURE WAS COMPLETED USING A TOTAL OF TEN SMART COILS AND THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6720107 ↗