Smart Coil 400SMTSFT0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548015118), received between Aug 21, 2015 and Nov 2, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL USING A GRASPER. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737790 ↗
• MalfunctionAug 26, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR CEREBELLAR ARTERY (SCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK IN THE INITIAL POSITION. 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 Consequences Or Impact To Patient

  MAUDE report 10454450 ↗
• InjuryNov 5, 2019Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) AND BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST SMART COIL IN THE ANEURYSM USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), THE COIL HERNIATED OUT OF THE ANEURYSM AND INTO THE BASILAR ARTERY. THEREFORE, THE PHYSICIAN USED A VELOCITY AND A NON-PENUMBRA STENT RETRIEVER TO REMOVE THE SMART COIL. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE COIL HERNIATION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281176 ↗
• MalfunctionApr 5, 2019Failure 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). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED THE FIRST SMART COIL INTO THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE SECOND SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND REPORTED THAT HE WAS UNABLE TO ADVANCE THE COIL PAST ITS INITIAL POSITION. THE SMART COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. 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 8487744 ↗
• InjuryMar 12, 2019Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (RMCA) USING PENUMBRA SMART COILS (SMART COILS). DURING IMPLANTATION OF A 1X1 SMART COIL, THE IMPLANTED 2X3 SMART COIL WAS PUSHED OUT OF THE TARGET VESSEL. THE 2X3 SMART COIL THEN MIGRATED OUT OF THE RMCA ANEURYSM INTO THE M3 SEGMENT OF THE MCA. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE 2X3 SMART COIL USING A SNARE DEVICE, THE COIL WAS LEFT IN THE M3, THE 1X1 SMART COIL WAS NOT USED AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413592 ↗
• MalfunctionDec 27, 2017Material Too Rigid or Stiff; Failure to Advance; Physical Resistance; Material Too Rigid or Stiff; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE SMART COIL ¿FELT STIFF¿. THE PROCEDURE WAS THEN 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 7148285 ↗
• MalfunctionDec 13, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN ARTERIOVENOUS FISTULA USING PENUMBRA SMART COILS (SMART COIL) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THE INITIAL SMART COILS USING THE HANDLE. WHILE ATTEMPTING TO DETACH A NEW SMART COIL USING THE SAME HANDLE, THE SMART COIL FAILED TO DETACH ON THE FIRST ATTEMPT; HOWEVER, THE SMART COIL THEN SUCCESSFULLY DETACHED ON THE SECOND ATTEMPT. IT WAS NOTED THAT AFTER DETACHING THE SMART COIL, IT WAS DIFFICULT TO REMOVE THE SMART COIL PUSHER ASSEMBLY FROM THE HANDLE. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6171358 ↗
• MalfunctionFeb 19, 2016Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING SMART COILS. THE PHYSICIAN SUCCESSFULLY DELIVERED THE FIRST SMART COIL (LOT # F65143) IN THE ANEURYSM USING ANOTHER MANUFACTURER'S MICROCATHETER AND GUIDE WIRE. UPON ADVANCING A SECOND SMART COIL IN THE ANEURYSM, THE FIRST SMART COIL BECAME DISLODGED AND APPROXIMATELY 3CM OF THE COIL MIGRATED INTO THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA). THE PHYSICIAN REMOVED THE SECOND SMART COIL AND USED A SNARE DEVICE AND ANOTHER MANUFACTURER'S MICROCATHETER IN ORDER TO RETRIEVE THE PROXIMAL END OF THE FIRST SMART COIL. AFTER A FEW ATTEMPTS TO RETRIEVE THE SMART COIL, THE SNARE DEVICE RUPTURED THE VESSEL. PRIOR TO ANY INTERVENTION BY THE PHYSICIAN, THE BLEEDING STOPPED. THE FIRST SMART COIL WAS LEFT IN THE PCA AND THE PROCEDURE WAS COMPLETED USING THE SECOND SMART COIL, THAT HAD PREVIOUSLY BEEN REMOVED, AND THREE ADDITIONAL SMART COILS. ONE SMART COIL (LOT # F65207) WAS DAMAGED BY THE TECHNICIAN ON THE BACK TABLE AND IT WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 5446986 ↗
• MalfunctionNov 18, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE SMART COIL INTO THE INTRODUCER SHEATH AND THEN INTRODUCED THE SHEATH INTO ANOTHER MANUFACTURER'S MICROCATHETER. THE SMART COIL WAS UNABLE TO BE TRANSFERRED INTO THE MICROCATHETER BECAUSE IT WOULD NOT ADVANCE OUT OF THE SHEATH. THE PHYSICIAN REMOVED THE SHEATH CONTAINING THE SMART COIL AND SUCCESSFULLY COMPLETED THE PROCEDURE 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 5234544 ↗
• MalfunctionAug 21, 2015Difficult to Advance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE MICROCATHETER KICKED OUT OF THE ANEURYSM AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL FULLY INTO THE ANEURYSM. THE SMART COIL WAS REMOVED AND THE PHYSICIAN USED A NEW SMART COIL. WHILE ADVANCING THE NEW SMART COIL THROUGH THE MICROCATHETER, RESISTANCE WAS MET AND BOTH THE SMART COIL AND THE MICROCATHETER WERE REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5023074 ↗
• MalfunctionAug 21, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE MICROCATHETER KICKED OUT OF THE ANEURYSM AND THE PHYSICIAN WAS UNABLE TO FULLY ADVANCE THE SMART COIL INTO THE ANEURYSM. THE SMART COIL WAS REMOVED AND THE PHYSICIAN USED A NEW SMART COIL. WHILE ADVANCING THE NEW SMART COIL THROUGH THE MICROCATHETER, RESISTANCE WAS MET AND BOTH THE SMART COIL AND THE MICROCATHETER WERE REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5023032 ↗