Smart Coil 400SMTSTD0620Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548014678), received between Dec 9, 2015 and Oct 25, 2021 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2021Failure 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, TWO SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITION. THE FIRST SMART COIL WAS REMOVED FROM THE INTRODUCER SHEATH BY CUTTING OFF THE INTRODUCER SHEATH, THEN ADVANCED TO THE TARGET LOCATION, AND DETACHED INTO THE ANEURYSM. THE SECOND SMART COIL WAS UNABLE TO ADVANCE PAST THE ITS INITIAL POSITION AFTER MULTIPLE ATTEMPTS AND WAS REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE USING THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694979 ↗
• MalfunctionAug 6, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  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), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL; HOWEVER, THE DETACHED SMART COIL REMAINED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE SMART COIL BACK INTO THE ANEURYSM. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THREE OTHER SMART COILS. THE THREE SMART COILS FAILED TO DETACH USING THE HANDLE. HOWEVER, THE PHYSICIAN MANUALLY DETACHED THE THREE SMART COILS INSIDE THE MICROCATHETER AND THEN USED THEIR RESPECTIVE PUSHER ASSEMBLIES TO PUSH THE SMART COILS BACK INTO THE ANEURYSM SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL NON-PENUMBRA 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 12291334 ↗
• MalfunctionApr 13, 2021Separation Failure; Separation Failure

  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. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN USED THE HANDLE TO SUCCESSFULLY IMPLANT THREE SMART COILS IN THE TARGET LOCATION. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE HANDLE DID NOT DETACH IT AFTER MORE THAN THREE ATTEMPTS WERE MADE TO DO SO. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL SMART COIL, 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 11658178 ↗
• MalfunctionDec 31, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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; No Consequences Or Impact To Patient

  MAUDE report 11102184 ↗
• MalfunctionNov 20, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK; 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 THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10878325 ↗
• MalfunctionDec 18, 2019Failure to Advance; Failure to Advance

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492028 ↗
• MalfunctionSep 24, 2018Failure 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, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, DESPITE GENTLY PUSHING AND PULLING THE PUSHER ASSEMBLY. THE SMART COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902723 ↗
• MalfunctionJun 29, 2018Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO AN ACCESS SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL BECAME STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH AND WOULD NOT ENTER THE ACCESS SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME ACCESS SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652776 ↗
• MalfunctionApr 23, 2018Separation 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 PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A SMART COIL WITHIN THE TARGET LOCATION USING THE HANDLE, AND THEREFORE THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEREFORE COMPLETED USING NEW 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 7452485 ↗
• MalfunctionDec 19, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ASCENDING AORTA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE SMART COILS USING A NON-PENUMBRA MICROCATHETER, BUT ALSO FELT RESISTANCE ADVANCING FOUR SMART COILS OUT OF THE MICROCATHETER AND INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING DIFFICULTY SEEING WHEN THE SMART COILS EXITED THE MICROCATHETER, AND THEREFORE THE PHYSICIAN WAS UNSURE WHETHER THE RESISTANCE WAS CAUSED BY THE MICROCATHETER POSITIONING, A POSSIBLE KINK IN THE MICROCATHETER, OR WHETHER THE RESISTANCE WAS DUE TO THE SMART COILS. THE FOUR SMART COILS WERE THEREFORE RETRACTED, AND THE PROCEDURE WAS CONTINUED USING SHORTER SMART COILS. THE PROCEDURE WAS THEN COMPLETED USING A LANTERN DELIVERY MICROCATHETER AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131098 ↗
• MalfunctionDec 6, 2017Failure 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, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER, AND THEREFORE THE SMART COIL WAS REMOVED. THE HOSPITAL STAFF ATTEMPTED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE, HOWEVER WAS STILL UNABLE TO. THE PROCEDURE WAS THEN COMPLETED USING A NEW SMART 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 7089037 ↗
• MalfunctionAug 22, 2017Fracture; Retraction Problem; Physical Resistance; Fracture; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED AN INTRALUMINAL SUPPORT STENT DEVICE IN THE NECK PORTION OF THE ANEURYSM. NEXT, THE PHYSICIAN DEPLOYED A SMART COIL INTO THE TARGET VESSEL AS THE FIRST FRAMING COIL BY THE JAILING TECHNIQUE USING A NON-PENUMBRA MICROCATHETER. HOWEVER, AFTER DETACHING THE SMART COIL, THE PHYSICIAN ATTEMPTED TO RETRACT THE SMART COIL PUSHER ASSEMBLY FROM THE MICROCATHETER BUT ENCOUNTERED RESISTANCE. SUBSEQUENTLY, ABOUT THREE CENTIMETERS OF THE TIP OF THE PUSHER ASSEMBLY BECAME FRACTURED INSIDE THE NON-PENUMBRA ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE RHV WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW RHV AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811922 ↗
• MalfunctionDec 29, 2016Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL THROUGH THE BENCHMARK SELECT CATHETER (BENCHMARK SELECT) AND THEN ATTEMPTED TO DEPLOY THE COIL INTO THE PATIENT. HOWEVER, THE COIL DID NOT TAKE ITS INTENDED SHAPE IN THE ANEURYSM AND REMAINED STRAIGHT. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL AND COMPLETED THE PROCEDURE USING NON-PENUMBRA COILS AND THE SAME BENCHMARK SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. PLEASE NOTE THAT THE DATE OF EVENT IS BEING LEFT BLANK BECAUSE THE MANUFACTURER IS WAITING ON CLARIFICATION FROM THE CUSTOMER FOR THE CORRECT DATE OF EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6213350 ↗
• MalfunctionAug 31, 2016Fracture; Difficult or Delayed Activation; Mechanical Jam; Fracture; Difficult or Delayed Activation; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A AURAL ARTERIOVENOUS FISTULA (D-AVF) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER BEFORE DEPLOYING AND DETACHING A SMART COIL IN THE TARGET VESSEL USING THE HANDLE. NEXT, THE PHYSICIAN DEPLOYED A NEW SMART COIL IN THE TARGET VESSEL; HOWEVER, UPON ATTEMPTING TO DETACH THE SMART COIL USING THE HANDLE, IT FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THIS SMART COIL AGAIN USING THE SAME HANDLE AND IT SUCCESSFULLY DETACHED AND WAS IMPLANTED IN THE TARGET VESSEL. HOWEVER, THE PROXIMAL PORTION OF THE SMART COIL PUSHER ASSEMBLY BECAME FRACTURED AND WAS STUCK IN THE HANDLE. THEREFORE, THE PUSHER ASSEMBLY ANS THE HANDLE WERE REMOVED AND THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING SEVERAL NON-PENUMBRA COILS IN THE TARGET VESSEL. NEXT, THE PHYSICIAN DEPLOYED AND DETACHED A NEW SMART COIL IN THE TARGET VESSEL USING A NEW HANDLE WITH NO ISSUES. THE PROCEDURE ENDED AT THAT POINT AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5919538 ↗
• MalfunctionDec 9, 2015Activation, Positioning or Separation Problem; Device Operational Issue

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) . DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DETACHING FIVE SMART COILS IN SEQUENCE USING THE HANDLE; HOWEVER, THE SMART COILS DETACHED AFTER MULTIPLE ATTEMPTS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5279934 ↗