Smart Coil 400SMTSFT4H10Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00814548017051), received between Mar 29, 2017 and Feb 17, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023Difficult 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), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE COIL DID NOT DETACH. THEREFORE, THE HANDLE WAS REMOVED AND EXCHANGED FOR A NEW ONE. THE PHYSICIAN ATTEMPTED TO DETACH THE SAME SMART COIL USING THE NEW HANDLE; HOWEVER, THE COIL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS. WHILE RETRACTING THE SMART COIL THROUGH THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE SMART COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE AND THE MICROCATHETER WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, A NEW HANDLE, FIFTEEN NON-PENUMBRA COILS, AND THE NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398957 ↗
• MalfunctionMar 4, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL (F109435) AS THE FIRST COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN THEN PULLED BACK ON THE MICROCATHETER AND ATTEMPTED AGAIN TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE COIL STILL WOULD NOT DETACH. SUBSEQUENTLY, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE, AND THE SMART COIL ALSO FAILED TO DETACH USING A SECOND HANDLE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL FROM THE MICROCATHETER. WHILE RETRACTING THE SMART COIL FROM THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN DECIDED TO LEAVE THE SMART COIL IN PLACE SINCE MOST OF THE SMART COIL WAS IN THE ANEURYSM AND ONLY THE TAIL OF THE COIL REMAINED OUTSIDE OF THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL (F102575) TO THE ANEURYSM AND ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675842 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WITHOUT ANY PROCEDURAL COMPLICATIONS OR DEVICE MALFUNCTIONS. ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND AN ISCHEMIC STROKE IN THE IPSILATERAL M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS NOTED. SUBSEQUENTLY, THE PATIENT¿S BLOOD PRESSURE WAS MONITORED. THE PATIENT WAS ALSO ADMINISTERED MILD HEPARIN AND NO PROGRESSION OF THE STROKE WAS OBSERVED. THE PATIENT WAS IN STABLE CONDITION, INTUBATED AND ON ANALGESICS. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY WITH CLINICAL SEQUELAE. ON (B)(6) 2021, INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS UNRELATED TO THE SMART COILS AND PROBABLY RELATED TO THE INDEX PROCEDURE. ON 23-SEP-2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS POSSIBLY RELATED TO THE SMART COILS.

  Patient problems: Ischemia Stroke

  MAUDE report 12651496 ↗
• MalfunctionMar 29, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS, CALCIFIED AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL IN THE TARGET LOCATION. SUBSEQUENTLY, AFTER ADVANCING THE NEXT SMART COIL A FEW CENTIMETERS IN THE INTRODUCER SHEATH, THE SMART COIL WAS STUCK. THE PHYSICIAN MADE ANOTHER ATTEMPT BUT WAS UNABLE TO ADVANCE THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 11581654 ↗
• MalfunctionNov 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A NEUROVASCULAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE FRICTION LOCK OF THE SMART COIL AND AS THE SMART COIL WAS ADVANCED THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED AND PLACED ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING TWO NEW SMART COILS. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 10908440 ↗
• MalfunctionMar 27, 2020Difficult to Advance; Physical Resistance/Sticking; Difficult 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 9892178 ↗
• MalfunctionDec 20, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  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 ATTEMPTED TO ADVANCE THE FIRST SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, AND FELT STRONG RESISTANCE. THE SMART COIL ONLY ADVANCED APPROXIMATELY 9CM INTO THE MICROCATHETER AND BECAME STUCK INSIDE. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL INTO THE TARGET VESSEL BUT COULD NOT DETACH IT USING THE HANDLE AND IT RETREATED 2CM INTO THE MICROCATHETER. A SECOND ATTEMPT WAS THEN MADE TO DETACH THE SMART COIL AND THE SAME ISSUE OCCURRED AND THE SMART COIL RETREATED 1CM INTO THE MICROCATHETER. THE PHYSICIAN THEN MANUALLY DETACHED THE COIL, HOWEVER, PART OF THE SMART COIL REMAINED IN THE MICROCATHETER. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL WAS USED TO ADVANCE THE SMART COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS 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 8187664 ↗
• MalfunctionDec 20, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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 ATTEMPTED TO ADVANCE THE FIRST SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, AND FELT STRONG RESISTANCE. THE SMART COIL ONLY ADVANCED APPROXIMATELY 9CM INTO THE MICROCATHETER AND BECAME STUCK INSIDE. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL INTO THE TARGET VESSEL BUT COULD NOT DETACH IT USING THE HANDLE AND IT RETREATED 2CM INTO THE MICROCATHETER. A SECOND ATTEMPT WAS THEN MADE TO DETACH THE SMART COIL AND THE SAME ISSUE OCCURRED AND THE SMART COIL RETREATED 1CM INTO THE MICROCATHETER. THE PHYSICIAN THEN MANUALLY DETACHED THE COIL, HOWEVER, PART OF THE SMART COIL REMAINED IN THE MICROCATHETER. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL WAS USED TO ADVANCE THE SMART COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS 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 8187658 ↗
• MalfunctionMar 7, 2018Physical Resistance; Physical Resistance

  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 INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE UPON PASSING THROUGH THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN WAS THEN ABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH OUTSIDE OF THE PATIENT¿S BODY. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS. THE PROCEDURE WAS COMPLETED USING 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 7320831 ↗
• MalfunctionOct 20, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CEREBRAL ANEURYSM (BA-TOP) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED TWO SMART COILS INTO THE TARGET VESSEL BUT WAS UNABLE TO DETACH THE COILS USING THE HANDLE. AFTER A COUPLE OF ATTEMPTS USING THE SAME HANDLE, BOTH COILS FINALLY DETACHED SUCCESSFULLY. THE PHYSICIAN THEN DEPLOYED A NEW SMART COIL IN THE TARGET AND ATTEMPTED TO DETACH IT USING A NEW HANDLE. AFTER THE FIRST ATTEMPT, IT WAS CONFIRMED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE COIL PUSHER ASSEMBLY BECAME SEPARATED ABOUT THREE MILLIMETERS. AFTER MAKING ADDITIONAL ATTEMPTS, THE BLACK ALIGNMENT ZONE PEELED OFF AND PULLED INTO THE HANDLE. IT WAS FLUOROSCOPICALLY OBSERVED THAT THE SMART COIL WAS DETACHED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6967020 ↗
• MalfunctionOct 7, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO INITIAL NON-PENUMBRA COILS INTO THE TARGET VESSEL. AFTER THAT, THE PHYSICIAN DEPLOYED A SMART COIL INTO THE TARGET VESSEL AND THEN ATTEMPTED TO DETACH THE COIL USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). ALTHOUGH IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE WAS SEPARATED, THE SMART COIL WAS NOT SUCCESSFULLY DETACHED. AFTER THREE ADDITIONAL ATTEMPTS WERE MADE USING THE SAME HANDLE, THE SMART COIL WAS DETACHED. THE PHYSICIAN THEN DECIDED TO OPEN A NEW HANDLE. THEREFORE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ADDITIONAL SMART COIL AND THE NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6926441 ↗
• MalfunctionAug 14, 2017Positioning Failure; Separation Failure; Positioning Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR CAROTID ARTERY (ACA) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, BUT WHILE ATTEMPTING TO DETACH THE SMART COIL USING THE HANDLE THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) WAS SEPARATED ENOUGH; HOWEVER, UPON VISUAL AND FLUOROSCOPIC INSPECTION, THE PHYSICIAN NOTICED THAT THE SMART COIL WAS NOT SUCCESSFULLY DETACHED. THE PHYSICIAN THEN MADE A COUPLE OF MORE ATTEMPTS; HOWEVER, THE SMART COIL WOULD STILL NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING SEVEN NON-PENUMBRA 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 6793418 ↗
• MalfunctionMar 29, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S CATHETER AND MICROCATHETER IN THE TARGET VESSEL THEN ATTEMPTED TO ADVANCE A SMART COIL THROUGH THE MICROCATHETER. HOWEVER, RESISTANCE WAS EXPERIENCED AND THE SMART COIL BECAME STUCK AND UNABLE TO MOVE FURTHER ABOUT 3-5MM FROM THE DETACHMENT POINT. THE PHYSICIAN THEN REPOSITIONED THE MICROCATHETER BUT THE SMART COIL REMAINED STUCK; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME FAILURE EVENT OCCURRED AND THEREFORE, THE SMART COIL WAS REMOVED AS WELL. THE PROCEDURE WAS 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 6443185 ↗