Smart Coil 400SMTSTD0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548014524), received between May 31, 2016 and Feb 23, 2021 — classified as 15 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. 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.

• MalfunctionFeb 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE SMART COILS IN THE INFERIOR MESENTERIC ARTERY (IMA) AND TWO SMART COILS IN THE IIA. IT WAS REPORTED THAT THE MICROCATHETER HAD BEEN FLUSHED THOROUGHLY; HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED, THE MICROCATHETER WAS FLUSHED AGAIN, AND THE SMART COIL WAS RE-ADVANCED. HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WAS THEREFORE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SEVEN 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 11366282 ↗
• MalfunctionSep 4, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS (F88573 AND F84429) WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS, AND ONE SMART COIL (F87328) WOULD NOT ADVANCE THROUGH THE NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962977 ↗
• MalfunctionAug 2, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL. WHILE ADVANCING A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING TWO 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 8854991 ↗
• MalfunctionMay 22, 2019Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER AND THE HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH A SECOND SMART COIL USING NEITHER THE HANDLE NOR MANUAL DETACHMENT. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE SMART COIL; HOWEVER, THE SMART COIL DETACHED WHILE BEING RETRACTED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A GUIDEWIRE TO PLACE THE DETACHED SMART COIL IN THE TARGET LOCATION. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER, A NEW COIL, AND TWO NEW SMART COILS. IT WAS REPORTED THAT A METAL FRAGMENT FROM THE PUSHER ASSEMBLY OF THE SECOND SMART COIL WAS FOUND IN THE HUB OF THE REMOVED MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631746 ↗
• MalfunctionMar 7, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SMART COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO PLACE A NEW SMART COIL AS THE NINTH COIL IN THE TARGET VESSEL, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL FROM ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH, DESPITE FLUSHING THE COIL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS 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 8402103 ↗
• MalfunctionSep 28, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NON-PENUMBRA MICROCATHETER INTO THE TARGET LOCATION AND ATTEMPTED TO PLACE A SMART COIL, HOWEVER, THE PHYSICIAN REPEATEDLY ADVANCED AND RETRACTED THE SMART COIL TO REPOSITION IT. CONSEQUENTLY, THE PHYSICIAN BEGAN TO EXPERIENCE RESISTANCE WHILE ADVANCING NEAR THE DISTAL TIP OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THIS THEN OCCURRED WITH A SECOND SMART COIL. THE PHYSICIAN THEN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET LOCATION, HOWEVER, WAS UNABLE TO DETACH THE COIL USING THE HANDLE. IT WAS REPORTED THAT THERE WAS AN ABNORMAL SOUND WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH THE HANDLE. THE PHYSICIAN THEREFORE USED A SECOND HANDLE TO DETACH THE SMART COIL. THE PROCEDURE WAS THEN COMPLETED USING THE SECOND HANDLE AND ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919197 ↗
• MalfunctionSep 28, 2018Difficult or Delayed Positioning; Physical Resistance/Sticking; Difficult or Delayed Positioning; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NON-PENUMBRA MICROCATHETER INTO THE TARGET LOCATION AND ATTEMPTED TO PLACE A SMART COIL, HOWEVER, THE PHYSICIAN REPEATEDLY ADVANCED AND RETRACTED THE SMART COIL TO REPOSITION IT. CONSEQUENTLY, THE PHYSICIAN BEGAN TO EXPERIENCE RESISTANCE WHILE ADVANCING NEAR THE DISTAL TIP OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THIS THEN OCCURRED WITH A SECOND SMART COIL. THE PHYSICIAN THEN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET LOCATION, HOWEVER, WAS UNABLE TO DETACH THE COIL USING THE HANDLE. IT WAS REPORTED THAT THERE WAS AN ABNORMAL SOUND WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH THE HANDLE. THE PHYSICIAN THEREFORE USED A SECOND HANDLE TO DETACH THE SMART COIL. THE PROCEDURE WAS THEN COMPLETED USING THE SECOND HANDLE AND ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919033 ↗
• MalfunctionSep 13, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 7873242 ↗
• MalfunctionJun 22, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS AND OTHER COILS. THE PHYSICIAN THEN WAS UNABLE TO DETACH TWO PENUMBRA SMART COILS (SMART COILS) USING THE HANDLE AND, THEREFORE, THE SMART COILS WERE MANUALLY DETACHED BY BENDING THE PUSHER ASSEMBLIES. 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 7631797 ↗
• MalfunctionMar 9, 2018Detachment Of Device Component; Physical Resistance; Positioning Problem; Detachment Of Device Component; Physical Resistance; Positioning Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT TRAVERSE SINUS TO TREAT A DURAL ARTERIOVENOUS FISTULA (D-AVF) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS AND THERE WAS SLIGHT STENOSIS. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN NON-PENUMBRA COILS AND ONE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO PLACE A NEW SMART COIL IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE SMART COIL DID NOT PACK WELL AND DECIDED TO REMOVE IT; HOWEVER, WHILE ATTEMPTING TO RETRACT THE SMART COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL AND REMOVED THE COIL. THE MICROCATHETER WAS THEN REINSERTED INTO THE PATIENT¿S BODY AND THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329196 ↗
• 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 7131139 ↗
• MalfunctionJun 30, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND TWO PENUMBRA SMART COIL DETACHMENT HANDLES (SCH1S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL USING A SCH1. THE PHYSICIAN WAS THEN UNABLE TO DETACH ANOTHER SMART COIL USING THE SCH1; THEREFORE, A NEW SCH1 WAS OPENED AND THE SMART COIL WAS SUCCESSFULLY DETACHED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ADDITIONAL COILS. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY DETACHED ANOTHER SMART COIL; HOWEVER WAS ABLE TO DETACH AFTER THREE ATTEMPTS WITH A SCH1. A NEW SCH1 WAS THEN OPENED TO BE USED WITH FURTHER COILS. AFTER SUCCESSFULLY PLACING MORE COILS, THE PHYSICIAN AGAIN EXPERIENCED DIFFICULTY DETACHING ANOTHER SMART COIL; HOWEVER THE SMART COIL WAS ABLE TO BE DETACHED ON THE SECOND ATTEMPT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6682768 ↗
• MalfunctionJun 14, 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 BASILAR BIFURCATION ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (SCH1S). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DETACHING A SMART COIL USING A SCH1. IT WAS REPORTED THAT THE ¿T¿ MARK WAS IN PLACE FOR THE DETACHMENT; HOWEVER, THE SMART COIL WOULD NOT DETACH. AFTER THREE FAILED ATTEMPTS, A NEW SCH1 WAS OPENED; HOWEVER, THE SMART COIL WOULD STILL NOT DETACH. THEREFORE, THE SMART COIL WAS MANUALLY DETACHED. THE PROCEDURE WAS COMPLETED USING A TOTAL OF FIFTEEN COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641762 ↗
• MalfunctionMar 9, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AFTER ADVANCING THE COIL ABOUT EIGHTY CENTIMETERS FROM THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE SMART COIL BECAME STUCK AND WAS UNABLE TO ADVANCE FURTHER. THEREFORE, THE SMART COIL WAS REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 6393878 ↗
• MalfunctionMay 31, 2016Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS FELL ONTO THE FLOOR PRIOR TO BEING USED. THEREFORE, BOTH COILS WERE NOT USED FOR THE PROCEDURE AND DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS.

  Patient problems: No Patient Involvement

  MAUDE report 5690165 ↗