Smart Coil 400SMTSFT0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548015033), received between Dec 30, 2015 and Oct 20, 2021 — classified as 1 injury, 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTRACRANIAL VESSELS USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12667886 ↗
• MalfunctionAug 31, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A 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 SIX OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389958 ↗
• MalfunctionAug 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO 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

  MAUDE report 12344869 ↗
• MalfunctionFeb 3, 2021Failure 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 WOULD NOT ADVANCE FROM THE STARTING POSITIONS OF THEIR INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11276696 ↗
• MalfunctionNov 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE V4 SEGMENT OF THE POSTERIOR CIRCULATION USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATH AND WAS STUCK AT THE STARTING POSITION. 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; No Consequences Or Impact To Patient

  MAUDE report 10789970 ↗
• MalfunctionMar 27, 2020Failure 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 IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE SMART COIL INTO THE ANEURYSM, THE PHYSICIAN HAD DIFFICULTY AND THE SMART COIL KICKED THE MICROCATHETER OUT OF THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PLACE THE SMART COIL IN THE ANEURYSM. THE PHYSICIAN THEN HAD DIFFICULTY WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE ANEURYSM; THEREFORE, THE PHYSICIAN RE-SHEATHED THE SMART COIL THEN REMOVED THE MICROCATHETER. NEXT, THE PHYSICIAN PLACED ANOTHER MICROCATHETER AND ATTEMPTED TO ADVANCE THE SAME SMART COIL INTO THE ANEURYSM; HOWEVER, THE SMART COIL KICKED THE MICROCATHETER OUT OF THE ANEURYSM. IT WAS ALSO REPORTED THAT THE SMART COIL DID NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER 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 9892179 ↗
• MalfunctionSep 10, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 8981152 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE BEYOND ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, IT WAS ALSO 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 8864374 ↗
• MalfunctionMay 14, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDLINE ANTERIOR CEREBRAL ARTERY (ACA) 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 USING THE HANDLE AND; THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS ENDED AFTER THE MANUAL DETACHMENT OF THE SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8610116 ↗
• MalfunctionOct 23, 2018Failure to Fold; Stretched; Failure to Fold; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA)/OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT¿S ANEURYSM HAD AN IRREGULAR SHAPE. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT CONFORM TO THE ANEURYSM AND KEPT FALLING OUT INTO THE PARENT VESSEL. UPON REMOVING THE SMART COILS, THE PHYSICIAN NOTICED THE SMART COILS PUSHER ASSEMBLIES WERE CURLED AND STRETCHED. THE PHYSICIAN ALSO COMMENTED THAT THE PUSHER ASSEMBLIES WERE VERY FLIMSY. THE PROCEDURE WAS COMPLETED WITHOUT PLACING ANY COILS IN THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7996008 ↗
• MalfunctionSep 17, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A SMART COIL USING A PENUMBRA SMART COIL HANDLE; THEREFORE, THE SMART COIL WAS DETACHED MANUALLY. THE PROCEDURE WAS COMPLETED USING EMBOSPHERES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882028 ↗
• MalfunctionMay 30, 2018Failure 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, AFTER INSERTING A SMART COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV) OF A NON-PENUMBRA MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE FROM ITS STARTING POSITION; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 7555557 ↗
• MalfunctionJan 17, 2018Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (D-AVF)USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE THREE SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE ROTATING HEMOSTATIC VALVE (RHV) ON THE NON-PENUMBRA MICROCATHETER, AND THEREFORE THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, THE SAME RHV 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 7200249 ↗
• InjuryApr 6, 2016Entrapment of Device; Migration or Expulsion of Device; Entrapment of Device; Migration or Expulsion of Device

  THE PATIENT WAS UNDERGOING A RE-TREATMENT COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AN INITIAL SMART COIL INTO THE ANEURYSM BUT DID NOT LIKE HOW THE LOOP OF THE COIL FELL AT THE NECK OF THE ANEURYSM SO HE READJUSTED THE POSITION OF THE COIL AND WAS STILL UNSATISFIED WITH THE PLACEMENT. THEREFORE, THE PHYSICIAN DECIDED TO RESHEATH THE SMART COIL AND CONTINUE THE PROCEDURE USING A NEW SMART COIL. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THIS NEW SMART COIL INTO THE ANEURYSM. HOWEVER, WHILE REMOVING THE MICROCATHETER, THE SMART COIL PULLED OUT OF THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL MASS BACK INTO THE ANEURYSM BUT WAS UNSUCCESSFUL AND SUBSEQUENTLY, THE COIL BECAME LODGED IN THE DISTAL MCA. THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE THE SMART COIL USING SNARE DEVICES BUT COULD NOT GET THE GUIDEWIRE AND MICROCATHETER TO THE COIL MASS. THE PHYSICIAN CONTINUED THE PROCEDURE BY IMPLANTING THREE COILS FROM ANOTHER MANUFACTURER INTO THE ANEURYSM. AFTER HOURS OF UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE SMART COIL MASS, THE PHYSICIAN ABORTED THE PROCEDURE. IT IS UNK

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 5551854 ↗
• MalfunctionDec 30, 2015Difficult or Delayed Activation; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PARAOPTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED SIX SMART COILS USING THE HANDLE. HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE NEXT THREE NEW SMART COILS USING THE HANDLE BUT THEY EVENTUALLY DETACHED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5337079 ↗
• MalfunctionDec 30, 2015Difficult or Delayed Activation; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PARAOPTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED SIX SMART COILS USING THE HANDLE. HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE NEXT THREE NEW SMART COILS USING THE HANDLE BUT THEY EVENTUALLY DETACHED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5336908 ↗