TARGET M0035476300Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540676559), received between Feb 9, 2017 and Sep 16, 2026 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  It was reported that the subject coil could not be advanced through the microcatheter. The subject coil was returned for analysis and it was discovered that the subject coil delivery wire was broken/fractured during use. The subject device was replaced, and the procedure was completed successfully. No clinical consequences were reported to the patient due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782607 ↗
• InjuryDec 5, 2025Fracture; Expulsion; Premature Separation; Fracture; Expulsion; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE PROCEDURE. HOWEVER, IT WAS NOTED THAT THE PACKAGING OF THE SUBJECT COIL WAS DAMAGED. ALSO, WHEN THE COIL WAS HALFWAY ASSEMBLED IN THE ANEURYSM IT GOT PREMATURELY DETACHED. THE PHYSICIAN DECIDED TO REMOVE THE COIL AND A SNARE WAS USED TO REMOVE THE COIL, HOWEVER ONCE THE SNARE WAS PLACED THE COIL PARTIALLY PROTRUDED FROM THE TARGET LOCATION; THUS, THE PHYSICIAN IMPLANTED ANOTHER STENT TO PRESS THE REMAINING COIL AGAINST ARTERY WALL, ONLY HALF OF THE COIL COULD BE REMOVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23729174 ↗
• InjuryApr 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE ON AN ATTEMPT TO PULL THE COIL (SUBJECT DEVICE) FROM THE ANEURYSM WHEN HE DIDN'T LIKE THE WAY THE COIL WAS DEPLOYING. THE COIL WAS NOT MOVING ON FURTHER ATTEMPTS OF PULLING INDICATING PREMATURE DETACHMENT OF THE COIL. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED COIL WITHOUT DISRUPTING THE STENTS OR THE ALREADY IMPLANTED COIL MASS. THE DELIVERY WIRE OF THE COIL WAS ALSO DAMAGED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 60 MINUTES. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858384 ↗
• MalfunctionApr 29, 2024Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) WAS FRACTURED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210071 ↗
• MalfunctionApr 23, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN TRIED TO RETURN THE SUBJECT COIL FROM ANEURYSM AFTER KICK BACK HOWEVER, COULD NOT MOVE THE SUBJECT COIL AND MICROCATHETER. THE SUBJECT COIL DEPLOYED PREMATURELY AND END OF THE COIL INVADED THE PARENT VESSEL. THE PHYSICIAN THEN DEPLOYED A STENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166762 ↗
• InjuryApr 12, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ANTERIOR COMMUNICATING ARTERY INTRACRANIAL LOBULATED ANEURYSM PROCEDURE, THE PATIENT CAME TO THE HOSPITAL AND WAS IN COMA. THE PHYSICIAN PLACED A MICROCATHETER TO GO INTO THE ANEURYSM AND DEPLOYED A STENT FIRST AND THEN PLACED ANOTHER MICROCATHETER TO PASS THE MESH OF THE STENT TO ANOTHER SAC OF THE ANEURYSM. PHYSICIAN USED FIRST MICROCATHETER TO FILL COILS AND THEN PREPARED TO USE THE SECOND MICROCATHETER TO FILL THE SUBJECT COIL. DURING THE ADJUSTMENT OF THE INSERTING OF THE SUBJECT COIL, THE PHYSICIAN CHECKED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY AND FOUND THE DELIVERY WIRE SEPARATED FROM THE SUBJECT COIL AND PART OF THE SUBJECT COIL WAS IN THE ANEURYSM AND PART WAS IN THE VESSEL AND THE REST WAS IN MICROCATHETER. SINCE A LONG SECTION OF THE COIL WAS NOT FILLED SUCCESSFULLY, PHYSICIAN WITHDREW THE MICROCATHETER AND TRIED TO USE MIDDLE CATHETER AND A BALLOON CATHETER TO TAKE THE SUBJECT COIL OUT (PRESSED THE SUBJECT COIL IN MIDDLE CATHETER) BUT FAILED BECAUSE THE SUBJECT COIL WAS SLIM. PHYSICIAN THEN USED A SNARE TO TAKE IT OUT BUT FAILED AGAIN. PHYSICIAN THEN USED A PERIPHERAL BALLOON TO TAKE THE COIL OUT. AFTER THAT DIGITAL SUBTRACTION ANGIOGRAPH

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19094924 ↗
• InjuryDec 14, 2023Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING THE ANTERIOR CAROTID ANEURYSM (ACA) PROCEDURE, THE OPERATOR USED COILS TO FILL THE ANEURYSM. THE OPERATOR PLACED THE MICROCATHETER AND THEN INSERTED THE SUBJECT COIL. DURING SUBJECT COIL ADJUSTMENT IN THE ANEURYSM IT FRACTURED AT THE DETACHMENT POINT AND PART OF IT MIGRATED INTO THE PARENT VESSEL. THE OPERATOR TRIED TO USE THE GUIDEWIRE TO TAKE THE FRAGMENT OUT BUT COULD NOT. THEN, THE OPERATOR FILLED THE REST OF THE COILS AND FINISHED THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCE'S WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326688 ↗
• MalfunctionAug 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT DEVICE (COIL) COULD NOT BE ADVANCED OUT OF THE MICROCATHETER AND WAS STRETCHED UPON WITHDRAWAL FROM THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL(SUBJECT DEVICE) WAS FOUND TO BE BROKEN/FRACTURE DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259314 ↗
• MalfunctionJun 6, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL DETACHED DURING THE PROCEDURE WHEN AN ATTEMPT WAS MADE TO RETRACT IT INTO THE MICROCATHETER TO REPOSITION THE SUBJECT COIL. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602785 ↗
• MalfunctionJun 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNRUPTURED PCOM ANEURYSM CASE THE SUBJECT COIL WAS DEPLOYED AS THE FIRST COIL. THE SUBJECT COIL WAS UNABLE TO MAINTAIN ITS SHAPE AND WAS NOT FRAMING PROPERLY. THE PHYSICIAN TRIED TO ADJUST THE SUBJECT COIL BUT IT GOT STRETCHED INSIDE THE ANEURYSM. HE THEN DECIDED TO REMOVE THE SUBJECT COIL FROM THE CATHETER BUT IT BROKE INSIDE THE PATIENT. SOME OF IT WAS IN THE ANEURYSM THE REST WAS TAKEN OUT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND COMPLETED THE PROCEDURE WITH SOME MORE COILS AND STENT. PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969954 ↗
• MalfunctionApr 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR RIGHT MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM, A COIL (SUBJECT DEVICE) WAS DELIVERED INTO LUMEN OF ANEURYSM WITH THE HELP OF A MICROCATHETER AND A GUIDEWIRE. DURING THE DELIVERY OF THE SUBJECT COIL, IT GOT STRETCHED AFTER IT JUST WENT INTO LUMEN OF ANEURYSM. IT WAS REPORTED THAT THE COIL WAS ADVANCED WITH FORCE INSIDE THE MICROCATHETER. WHEN THE PHYSICIAN WITHDREW THE SUBJECT COIL TO CHECK IT, THE SUBJECT COIL WAS SEPARATED FROM ITS DELIVERY WIRE. THE PREMATURELY DETACHED SUBJECT COIL WAS REMOVED SUCCESSFULLY FROM THE PATIENT'S ANATOMY THROUGH THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720850 ↗
• MalfunctionApr 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION PROCEDURE, THE COIL (SUBJECT DEVICE) WAS INSERTED AS A FIRST COIL. DURING INSERTION OF THE SUBJECT COIL, THE ANEURYSM HEMORRHAGED SUDDENLY. IT WAS CONFIRMED THAT THE ANEURYSM HEMORRHAGE WAS NOT RELATED TO THE DEVICES IN USE DURING THE PROCEDURE. THE PHYSICIAN'S ASSISTANT PRESSED THE ICA AND THE PHYSICIAN CONTINUED TO FILL THE SUBJECT COIL. WHEN THE SUBJECT COIL WAS ATTEMPTED TO DETACH, ITS PROXIMAL ELECTRODE (DELIVERY WIRE) WAS FOUND FRACTURED. THE PHYSICIAN WITHDREW THE FRACTURED PART AND THE SUBJECT COIL TO REPLACE IT WITH ANOTHER COIL. THE PHYSICIAN STOPPED THE HEMORRHAGE BY FILLING TWO COILS AND COMPLETED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665526 ↗
• InjuryJan 6, 2021Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL PREMATURELY DETACHED AND PROTRUDED OUT OF THE ANEURYSM. THE PHYSICIAN USED A CORONARY BALLOON CATHETER AS MEDICAL INTERVENTION TO PRESS THE SUBJECT COIL AGAINST THE GUIDE CATHETER AND FULLY REMOVE THE ENTIRE SYSTEM FROM THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE AND WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT. PATIENT UNDERWENT PROLONGED HOSPITAL STAY DUE TO UNKNOWN REASONS AS EVENT WAS SUCCESSFULLY RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128632 ↗
• MalfunctionOct 7, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED IN THE CATHETER DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENTS MEDICAL CONDITION WAS GOOD. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10645324 ↗
• MalfunctionAug 25, 2020Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT DEVICE WAS BROKEN DURING USE. THERE WERE NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451967 ↗
• MalfunctionDec 26, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL HAD PREMATURELY DEPLOYED DURING USE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521254 ↗
• MalfunctionMar 20, 2019Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED AND STRETCHED FROM THE ANEURYSM ALL THE WAY TO PUNCTURE POINT IN FEMORAL ARTERY. THERE WERE NO CONSEQUENCES REPORTED TO THE PATIENT DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438803 ↗
• InjuryDec 18, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING COIL EMBOLIZATION PROCEDURE FOR ANEURYSM LOCATED AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE PHYSICIAN WAS ABLE TO PLACE THE SUBJECT COIL INTO THE ANEURYSM; HOWEVER, THE COIL BECAME STRETCHED AND WAS PREMATURELY DETACHED FROM THE PRIMARY WIRE. THE PHYSICIAN ACCESSED THE VESSEL AND A MICROSNARE DEVICE WAS USED TO REMOVE THE COIL. THE PROCEDURE TOOK LONGER THAN IT WAS SUPPOSED TO HAVE, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR 1.5 HOURS DUE TO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8175350 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY. ON THE DAY OF THE PROCEDURE, THE PATIENT EXPERIENCED A FIRST HEADACHE. THE FIRST HEADACHE WAS RESOLVED THE NEXT DAY WITH NO RESIDUAL EFFECTS. TWO DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED A SECOND HEADACHE. THE SECOND HEADACHE WAS ONGOING. MEDICATION WAS ADMINISTERED TO TREAT THE HEADACHE (2MG DEXAMETHASONE AND 1 MG MORPHINE AND 650 MG ACETAMINOPHEN). POST PROCEDURE, AT 2-MONTH, 6-MONTH, AND 12-MONTH POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED HAVING A MODIFIED RANKIN SCALE (MRS) OF 1. AT 2-MONTH, 6-MONTH, AND 12-MONTH POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) OF 2. THE PHYSICIAN HAS INDICATED THAT THE 2 EVENTS OF HEADACHE WERE POSSIBLY RELATED TO THE INDEX PROCEDURE AND TO THE STENT AND NOT RELATED TO PRE-EXISTING CONDITION/CO-MORBIDITY. HOWEVER, IT IS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES) AND ACCESS DEVICES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6929156 ↗
• InjuryJul 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION WITH THE COIL (SUBJECT DEVICE), THE COIL STRETCHED WHILE DELIVERING INTO THE ANEURYSM. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT BODY WITH A SNARE DEVICE. THERE WERE NO PATIENT CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745954 ↗
• InjuryFeb 9, 2017Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  DURING THE EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE COIL BROKE WHILE WITHDRAWING THE MICROCATHETER FROM THE ANEURYSM. THE PART OF THE MAIN COIL WAS STILL ATTACHED TO THE DELIVERY WIRE AND 2 LOOPS OF THE MAIN COIL WERE PROTRUDING FROM THE ANEURYSM INTO THE PARENT VESSEL. THE BROKEN COIL WHICH WAS ATTACHED TO THE DELIVERY WIRE WAS SAFELY REMOVED FROM THE PATIENT. A STENT WAS PLACED ACROSS THE LESION TO SECURE PROTRUDED LOOPS OF THE COIL INSIDE THE ANEURISM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6316235 ↗