Smart Coil 400SMTSFT3H08Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814548017013), received between Jul 21, 2017 and Dec 21, 2021 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2021Stretched; Difficult or Delayed Separation; Stretched; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A SMART COIL IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT BLACK LINE ON THE PROXIMAL END OF THE SMART COIL WAS SEPARATED AND THE SMART COIL APPEARED TO HAVE BEEN DETACHED. THE PHYSICIAN THEN RETRACTED THE PUSHER ASSEMBLY OF THE SMART COIL AND NOTICED THE COIL WAS STILL ATTACHED. THE PHYSICIAN USED THE HANDLE AGAIN TO TRY AND DETACH THE SMART COIL; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL USING A HEMOSTAT, BUT THE SMART COIL STILL FAILED TO DETACH AND, THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, UPON RETRACTING, THE SMART COIL STRETCHED AND UNINTENTIONALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE DETACHED SMART COIL INTO THE ANEU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052887 ↗
• MalfunctionNov 30, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY 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 IN THE TARGET LOCATION 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 WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 12901354 ↗
• MalfunctionJun 7, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE SINUS USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL AND THREE OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN THEN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REPLACED THE MICROCATHETER WITH ANOTHER MICROCATHETER AND ATTEMPTED TO ADVANCE THE SAME SMART COIL THROUGH THE MICROCATHETER. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, ADDITIONAL SMART COILS, OTHER 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 11948580 ↗
• MalfunctionMar 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A HANDLE. DURING THE PROCEDURE, TWO SMART COILS FAILED TO DETACH USING THE SAME HANDLE. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACHING THE TWO SMART COILS; HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE TWO SMART COILS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED BY MANUALLY DETACHING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446814 ↗
• MalfunctionDec 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED EIGHT SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE SMART COIL HALFWAY INTO THE ANEURYSM AND THE COIL STARTED SNAKING WITHIN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME 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 11098312 ↗
• MalfunctionSep 4, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE SMART COILS SEPARATELY INTO THE AVM AND CLICKED ON THE HANDLE. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED TO A SECOND HANDLE AFTER EXPERIENCING THIS ISSUE WITH TWO TO THREE SMART COILS; HOWEVER, THE SECOND HANDLE FAILED TO DETACH THE REMAINING SMART COILS. THE PUSHER ASSEMBLY OF EACH SMART COIL INDICATED THE SMART COIL WAS DETACHED CORRECTLY, BUT BOTH HANDLE FAILED TO DETACH FIVE SMART COILS. THEREFORE, THE SMART COILS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497069 ↗
• MalfunctionNov 15, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN COAXIALLY ADVANCED TWO NON-PENUMBRA MICROCATHETERS IN THE TARGET VESSEL, THEN ADVANCED THE SMART COIL INTO THE TARGET VESSEL TO FRAME THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN DID NOT DETACH THE SMART COIL. NEXT, THE PHYSICIAN IMPLANTED FOUR NON-PENUMBRA COILS IN THE ANEURYSM, THEN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE TWO ATTEMPTS TO MANUALLY DETACH THE SMART COIL, BUT THESE ALSO FAILED. A FINAL ATTEMPT WAS MADE TO DETACH THE SMART COIL USING A MOSQUITO FORCEPS AND THE SMART COIL WAS SUCCESSFULLY DETACHED AND IMPLANTED INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING FOUR OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9329136 ↗
• MalfunctionNov 4, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL, THE SMART COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 9276086 ↗
• MalfunctionJul 19, 2018Failure to Fold; Failure to Advance; Physical Resistance/Sticking; Failure to Fold; 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 ATTEMPTED TO PLACE A SMART COIL USING A NON-PENUMBRA MICROCATHETER, HOWEVER, THE PHYSICIAN DID NOT LIKE HOW THE SMART COIL WAS FORMING WITHIN THE ANEURYSM, DESPITE REPOSITIONING IT SEVERAL TIMES. IT WAS REPORTED THAT THE PHYSICIAN ALSO FELT RESISTANCE WHILE ADVANCING THE SMART COIL WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE SMART COIL AND THE MICROCATHETER. THE PHYSICIAN THEN CHANGED THE TIP SHAPE OF THE MICROCATHETER AND REINSERTED THE SAME MICROCATHETER. HOWEVER, WHILE ATTEMPTED TO RE-INSERT THE SAME SMART COIL, IT WAS UNABLE TO ADVANCE THROUGH THE MIDDLE OF THE MICROCATHETER. THE SMART COIL WAS, THEREFORE, REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, 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 7704321 ↗
• InjuryJun 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 ANTERIOR COMMUNICATING ARTERY (ACOM) ON (B)(6) 2018 USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED NON-PENUMBRA COILS AND THREE SMART COILS. THE PATIENT THEN EXPERIENCED LEFT HEMIPARESIS FOUR HOURS AFTER THE EMBOLIZATION PROCEDURE. THE PATIENT WAS GIVEN AN INTEGRILIN BOLUS TO TREAT THE STROKE, AND THE PATIENT¿S NIHSS SCORE DECREASED FROM 12 TO 0 WITH RESIDUAL WEAKNESS OF THE LEFT LOWER EXTREMITY, WITH DORSIFLEXION AND PLANTAR FLEXION 2/5. THIS EVENT IS CONSIDERED RESOLVED AS OF (B)(6) 2018. THE STROKE WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL PROCEDURE, AND A PROBABLE RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Ischemia; Neurological Deficit/Dysfunction; Weakness

  MAUDE report 7603853 ↗
• MalfunctionFeb 21, 2018Detachment Of Device Component; Retraction Problem; Separation Failure; Detachment Of Device Component; Retraction Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY TO TREAT A RUPTURED CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS AND ONE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL DID NOT TO DETACH. AFTER THREE FAILED ATTEMPTS, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, DURING RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287374 ↗
• MalfunctionJan 17, 2018Detachment Of Device Component; Retraction Problem; Separation Failure; Detachment Of Device Component; Retraction Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). IT WAS NOTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. AFTER FOUR TO FIVE FAILED ATTEMPTS, THE PHYSICIAN BENT THE SMART COIL PUSHER ASSEMBLY AND PULLED THE PULL WIRE; HOWEVER, THE SMART COIL DID NOT DETACH. THE PHYSICIAN THEN DECIDED TO RETRACT THE SMART COIL; HOWEVER, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER AFTER BEING RETRACTED APPROXIMATELY TWO CENTIMETERS BACK INTO THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE COIL''S PUSHER ASSEMBLY TO PUSH THE DETACHED COIL INTO THE ANEURYSM. 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 7200221 ↗
• MalfunctionDec 5, 2017Difficult or Delayed Positioning; Separation Failure; Difficult or Delayed Positioning; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (A-COM) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A SMART COIL INTO THE TARGET VESSEL BUT WAS UNABLE TO DETACH THE COIL USING THE HANDLE. THEREFORE, A NEW HANDLE WAS OPENED AND THE SMART COIL WAS DETACHED WITHOUT AN ISSUE. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING THREE ADDITIONAL SMART COILS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085013 ↗
• MalfunctionJul 21, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA SHEATH INTO THE INTERNAL CEREBRAL ARTERY (ICA), THEN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH THE SHEATH AND INTO THE ANEURYSM. NEXT, THE PHYSICIAN DEPLOYED A SMART COIL INTO THE ANEURYSM BUT WAS UNABLE TO DETACH THE COIL USING THE HANDLE. AFTER THREE FAILED ATTEMPTS TO DETACH THE SMART COIL, THE PHYSICIAN REMOVED THE COIL AND COMPLETED THE PROCEDURE USING ANOTHER COIL WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6732528 ↗