Smart Coil 400SMTSTD0725Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548014555), received between Dec 3, 2015 and Aug 6, 2021 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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.

• MalfunctionAug 6, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL; HOWEVER, THE DETACHED SMART COIL REMAINED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE SMART COIL BACK INTO THE ANEURYSM. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THREE OTHER SMART COILS. THE THREE SMART COILS FAILED TO DETACH USING THE HANDLE. HOWEVER, THE PHYSICIAN MANUALLY DETACHED THE THREE SMART COILS INSIDE THE MICROCATHETER AND THEN USED THEIR RESPECTIVE PUSHER ASSEMBLIES TO PUSH THE SMART COILS BACK INTO THE ANEURYSM SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL 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 12291394 ↗
• MalfunctionJun 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPTHALMIC ARTERY USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. 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 12022165 ↗
• MalfunctionMay 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN LEFT SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION IN THE INTRODUCER SHEATH. 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

  MAUDE report 11866990 ↗
• MalfunctionFeb 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A NEURO FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE THREE SMART COILS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 11360011 ↗
• MalfunctionOct 21, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE SMART COIL ¿DID NOT DEPLOY¿. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED.

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

  MAUDE report 10715017 ↗
• MalfunctionMay 19, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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 10071027 ↗
• MalfunctionMay 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THREE SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ONE OF THE SMART COILS OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE, BUT IT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THREE OTHER SMART COILS THROUGH THE MICROCATHETER; HOWEVER, THE SMART COILS WERE ABLE TO BE SUCCESSFULLY IMPLANTED INTO THE ANEURYSM. 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 Consequences Or Impact To Patient

  MAUDE report 8584608 ↗
• InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THERE WAS A THROMBUS FORMATION IN THE RIGHT MIDDLE CEREBRAL ARTERY WHICH DID NOT CAUSE ANY NEUROLOGICAL DEFICITS. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT WAS RESOLVED THE SAME DAY (B)(6) 2017. THE EVENT WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM AND THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7806525 ↗
• MalfunctionMar 8, 2017Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S MICROCATHETER AND AN INTRACRANIAL STENT DEVICE TO COVER THE NECK OF CAVERNOUS ANEURYSM IN THE TARGET VESSEL, AND THEN INITIATED THE COIL EMBOLIZATION USING A JAILING TECHNIQUE. WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN HAD DIFFICULTY RIGHT BEFORE THE COIL PUSHER ASSEMBLY WAS INSIDE THE MICROCATHETER. ALTHOUGH THE SMART COIL INTRODUCER SHEATH WAS REMOVED FROM THE PROXIMAL PORTION OF THE PUSHER ASSEMBLY, THE PHYSICIAN STILL EXPERIENCED DIFFICULTY ADVANCING THE SMART COIL. HOWEVER, THE PHYSICIAN EVENTUALLY ADVANCED THE SMART COIL INTO THE MICROCATHETER BUT THE SMART COIL WAS REMOVED BECAUSE IT SMALL. THE PHYSICIAN THEN OPENED A NEW SMART COIL. ALTHOUGH THE PHYSICIAN NOTED THAT IT WAS ALSO DIFFICULT TO ADVANCE THE NEW SMART COIL THROUGH THE MICROCATHETER LIKE THE PREVIOUS SMART COIL; THE PHYSICIAN WAS ABLE TO ADVANCE AND IMPLANT IT INTO THE ANEURYSM. THE PHYSICIAN THEN SUCCESSFULLY RE-ADVANCED AND IMPLANTED THE FIRST SMART COIL THAT WAS REMOVED DUE TO THE SIZING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6387970 ↗
• MalfunctionFeb 23, 2017Failure to Advance; Failure to Advance

  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 WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND 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 6354943 ↗
• MalfunctionDec 7, 2016Failure to Advance; Failure to Advance

  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 OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED AND 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 6152370 ↗
• MalfunctionNov 21, 2016Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE FIRST SMART COIL OF THE PROCEDURE THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. HOWEVER, THE PHYSICIAN ADVANCED AND RETRACTED THIS SMART COIL MULTIPLE TIMES DESPITE THE RESISTANCE AND PLACED IT IN THE ANEURYSM. AFTER DEPLOYING THIS SMART COIL IN THE ANEURYSM, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL FROM THE PATIENT IN ORDER TO AVOID ANY ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, THE SAME NON-PENUMBRA MICROCATHETER, AND ADDITIONAL COILS. IN ADDITION, THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE AND MAINTAINING CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117557 ↗
• MalfunctionSep 8, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE,THE SECOND SMART COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE THIS SMART COIL WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME NON-PENUMBRA MICROCATHETER. THE PHYSICIAN MAINTAINED CONTINUOUS FLUSH AND USED A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5936283 ↗
• MalfunctionDec 3, 2015Failure to Advance

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PENUMBRA SMART COIL (SMART COIL) WAS STUCK IN ITS INTRODUCER SHEATH AND THE PHYSICIAN WAS UNABLE TO ADVANCE IT OUT OF THE SHEATH. THE PHYSICIAN DID NOT USE THE SMART COIL IN THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5265242 ↗
• MalfunctionDec 3, 2015Device Operates Differently Than Expected

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PENUMBRA SMART COIL (SMART COIL) WAS STUCK IN ITS INTRODUCER SHEATH AND THE PHYSICIAN WAS UNABLE TO ADVANCE IT OUT OF THE SHEATH. THE PHYSICIAN DID NOT USE THE SMART COIL IN THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW SMART COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5265235 ↗