Smart Coil 400SMTSTD1460Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548014289), received between Oct 30, 2017 and Nov 18, 2021 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840625 ↗
• MalfunctionSep 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAXILLARY ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WERE UNABLE TO ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509555 ↗
• MalfunctionMay 18, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE OUT OF 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

  MAUDE report 11841692 ↗
• MalfunctionNov 9, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), TWO NON-PENUMBRA MICROCATHETERS, AND A NON-PENUMBRA BALLOON CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING A MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING A MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A NEW HANDLE TO DETACH THE SMART COIL. THE PROCEDURE WAS COMPLETED USING SEVENTEEN SMART COILS, TWENTY-SEVEN NON-PENUMBRA COILS, THE SAME TWO MICROCATHETERS, AND THE SAME BALLOON CATHETER. 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 10810043 ↗
• MalfunctionNov 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID COMMUNICATING SEGMENT USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS ONLY ABLE TO ADVANCE THE SMART COIL PARTIALLY WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND OTHER 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 10804585 ↗
• MalfunctionSep 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SMART COIL BECAME STUCK. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE SMART COIL BACK INTO ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE SMART COIL AND THEN REMOVED THE SMART COIL. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER COILS, AND ANOTHER 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 10556568 ↗
• MalfunctionDec 11, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL (HANDLE). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED THE FIRST THREE SMART COILS IN THE TARGET VESSEL AFTER MAKING MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. WHILE ATTEMPTING TO PLACE FOURTH SMART COIL, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING A NEW HANDLE TO DETACH THE SAME FOURTH SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453858 ↗
• MalfunctionDec 11, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL (HANDLE). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED THE FIRST THREE SMART COILS IN THE TARGET VESSEL AFTER MAKING MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. WHILE ATTEMPTING TO PLACE FOURTH SMART COIL, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING A NEW HANDLE TO DETACH THE SAME FOURTH SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453850 ↗
• MalfunctionJan 24, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT A TYPE II ENDOLEAK USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO SMART COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND THE HANDLE. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL WOULD NOT DETACH. AFTER FIVE ATTEMPTS, THE SMART COIL FINALLY DETACHED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE BUT THE COIL DID NOT DETACH. AFTER SEVERAL ATTEMPTS, THE SMART COIL WOULD STILL NOT DETACH. THE PHYSICIAN THEN PARTIALLY PULLED BACK THE LEVER OF THE HANDLE AND MANUALLY HELD IT IN ORDER TO ADJUST THE FORCE; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN USED FORCEPS TO MANUALLY DETACH THE SMART COIL. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7217370 ↗
• 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 7131160 ↗
• MalfunctionOct 30, 2017Detachment Of Device Component; Premature Activation; Inadequacy of Device Shape and/or Size; Detachment Of Device Component; Premature Activation; Inadequacy of Device Shape and/or Size

  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 6988727 ↗