Smart Coil 400SMTSTD1260Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548014449), received between Oct 30, 2017 and Oct 13, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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 13, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL USING THE MICROCATHETER INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL THREE TIMES WITHOUT SUCCESS. WHILE ATTEMPTING TO RETRACT THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE SMART COIL INTO THE VESSEL AND FLUSHED IT. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL MANUALLY BUT WAS UNSUCCESSFUL. THE SMART COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932595 ↗
• MalfunctionApr 27, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL DUE TO ITS SIZE. WHILE RE-SHEATHING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED AND THE SMART COIL FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING OTHER 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 11733616 ↗
• MalfunctionApr 22, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, NON-PENUMBRA SHEATH, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE FIRST SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, TWO NEW SMART COILS WERE PLACED AND DETACHED IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AN ATTEMPT WAS MADE TO MANUALLY DETACH THE PUSHER ASSEMBLY OF THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710274 ↗
• InjurySep 18, 2020Material Deformation; Migration; Premature Separation; Material Deformation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE SMART COIL. WHILE RETRACTING THE SMART COIL TO REPOSITION IT, THE SMART COIL SEEMED TO HAVE KNOTTED ON ITSELF. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL AND MICROCATHETER TOGETHER, BUT THE SMART COIL UNINTENTIONALLY DETACHED AND MIGRATED DISTALLY DURING THE RETRACTION PROCESS. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED SMART COIL USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. A STRAND OF THE SMART COIL REMAINED IN THE ANTERIOR CEREBRAL ARTERY (ACA) AND ICA. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS TO SECURE THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT RELATED TO THE SMART COIL MIGRATION. IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER THE PROCEDURE BECAUSE OF COMPLICATIONS CAUSED BY THE SUBARACHNOID HEMORRHAGE.

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

  MAUDE report 10557453 ↗
• MalfunctionJun 7, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS INTO THE SAH USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN WAS UNABLE TO ADVANCE A NEW SMART COIL WITHIN ITS INTRODUCER SHEATH AND AFTER SEVERAL ATTEMPTS, THE SMART COIL PUSHER ASSEMBLY BECAME BENT AT THE PROXIMAL END OF THE 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 8679834 ↗
• MalfunctionApr 25, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PENUMBRA SMART COILS (SMART COIL) IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH A NEW SMART COIL USING TWO DIFFERENT HANDLES; THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS THEN COMPLETED USING NEW SMART COILS AND OTHER COILS WITH THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549200 ↗
• MalfunctionJan 10, 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 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATHS AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, BOTH SMART COILS WERE 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 8236597 ↗
• MalfunctionJan 4, 2019Failure 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 PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED NINETEEN COILS AND FOUR SMART COILS TO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH AS THE TWENTY-FOURTH COIL, THE PHYSICIAN FELT RESISTANCE AND COULD NOT ADVANCE THE SMART COIL ANY FURTHER. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, 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 8218667 ↗
• MalfunctionDec 28, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, DESPITE FLUSHING THE COIL AND ATTEMPTING MULTIPLE TIMES. THE PUSHER ASSEMBLY OF THE SMART COIL THEN BECAME KINKED DUE TO THE FORCE EXERTED WHILE TRYING TO ADVANCE IT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW SMART 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 8202617 ↗
• MalfunctionOct 25, 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 THROUGH THE HUB OF MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER FELT THE SAME RESISTANCE. THE PHYSICIAN ATTEMPTED TO FORCE THE COIL FORWARD AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME KINKED. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW 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 8007512 ↗
• MalfunctionOct 25, 2018Material Deformation; Material Deformation

  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 THROUGH THE HUB OF MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER FELT THE SAME RESISTANCE. THE PHYSICIAN ATTEMPTED TO FORCE THE COIL FORWARD AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME KINKED. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW 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 8007496 ↗
• MalfunctionMar 29, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE HUB OF A NON-PENUMBRA MICROCATHETER AND EXPERIENCED SLIGHT RESISTANCE. UPON CONTINUING TO PUSH THE SMART COIL, THE RESISTANCE BECAME STRONG AND THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 7381989 ↗
• 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 7217366 ↗
• MalfunctionDec 19, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE USING A SMART COIL WITH A NON-PENUMBRA MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED COIL INTO THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129555 ↗
• MalfunctionOct 30, 2017Detachment Of Device Component; Premature Activation; Detachment Of Device Component; Premature Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOMM) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED INITIAL NON-PENUMBRA COILS INTO THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER WITH NO RESISTANCE, THE PHYSICIAN FELT THAT THE COIL HAD UNINTENTIONALLY DETACH WITHIN THE MICROCATHETER. THE SMART COIL WAS HALFWAY OUTSIDE OF THE MICROCATHETER AND INTO THE ANEURYSM WHEN IT DETACHED. THEREFORE, THE PHYSICIAN USED THE SMART COIL PUSHER ASSEMBLY TO PUSH THE REMAINING AMOUNT OF COIL INTO THE ANEURYSM. THE PROCEDURE WAS THEN SUCCESSFULLY 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 6988149 ↗