TARGET M0035421030Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04546540697974), received between Oct 24, 2016 and Jun 23, 2026 — classified as 9 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (27 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS FOUND DETACHED FROM THE SUBJECT COIL DELIVERY WIRE. 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 25589739 ↗
• MalfunctionApr 14, 2026Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL PRE-DETACHED IN MICROCATHETER 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 24868089 ↗
• MalfunctionNov 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHILE ADVANCING SUBJECT COIL AND IT GOT PREMATURELY DETACHED IN THE MICROCATHETER. PHYSICIAN PULLED OUT COIL AND MICROCATHETER TOGETHER FROM PATIENTS' BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589569 ↗
• MalfunctionOct 24, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE 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 23376726 ↗
• MalfunctionJan 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT MAIN COIL WAS UNABLE TO DETACH USING THE POWER SUPPLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196740 ↗
• InjuryDec 19, 2024Expulsion; Expulsion

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS PLACED INTO THE MCA (MIDDLE CEREBRAL ARTERY) BIFURCATION ANEURYSM AS THE FINISHING COIL. THE COIL WAS DETACHED AND THREE BEEPS WERE NOTED FROM THE POWER SUPPLY. THE MICROCATHETER WAS REMOVED FROM THE ANEURYSM AND THE PHYSICIAN FOUND THAT THE SUBJECT COIL WAS STILL BRIEFLY ATTACHED TO THE DELIVERY WIRE WHICH RESULTED IN THE SUBJECT COIL TAIL PROTRUDING FROM THE ANEURYSM. A STENT WAS PLACED TO PIN THE PROTRUDING SUBJECT COIL TAIL AGAINST THE WALL OF THE VESSEL. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20974746 ↗
• MalfunctionSep 5, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) HAD A STRONG RESISTANCE INSIDE THE MICROCATHETER. DR. HAD NO CHOICE BUT TO PULL OUT THE COIL (SUBJECT DEVICE) IN THE MICROCATHETER AND DISCOVERED THAT THE COIL (SUBJECT DEVICE) IS PREMATURELY DETACHED PRIOR TO ITS RELEASE FROM HYPOTUBE. 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 17687728 ↗
• MalfunctionAug 28, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED INSIDE THE MICROCATHETER WHILE BEING ADVANCED THROUGH THE MICROCATHETER. 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 17630158 ↗
• MalfunctionJan 25, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DEPLOYED PREMATURELY WITHIN THE MICROCATHETER. 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 16238651 ↗
• MalfunctionNov 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN DELIVERED THE SUBJECT COIL USING A MICROCATHETER TO THE TARGET LESION. HE TRIED TO ADVANCE ANOTHER COIL USING THE SAME MICROCATHETER, HOWEVER THE COIL COULD NOT BE ADVANCED OUT OF MICROCATHETER. AFTER CHECKING, HE FOUND THAT THE SUBJECT COIL WAS DETACHED WITHIN THE MICROCATHETER AND WAS STUCK AT THE TIP OF THE MICROCATHETER. HE TRIED TO PUSH IT USING A GUIDEWIRE HOWEVER, THE SUBJECT COIL COULD NOT BE PUSHED OUT. THE PHYSICIAN THEN REMOVED THE SUBJECT COIL ALONG WITH THE MICROCATHETER. 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 15868636 ↗
• MalfunctionOct 24, 2022Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT COIL DETACHED PREMATURELY DURING USE IN THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657915 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ICA ANEURYSM PROCEDURE THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL(SUBJECT DEVICE) THROUGH A MICROCATHETER, THE RESISTANCE CAUSED THE PROXIMAL END OF COIL(SUBJECT DEVICE) DELIVERY WIRE TO BREAK INSIDE MICROCATHETER. THE COIL WAS THEN COMPLETELY REMOVED. 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 15422524 ↗
• MalfunctionJun 21, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL BROKE/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14764320 ↗
• MalfunctionApr 19, 2022Fracture; Fracture

  ON ANALYSIS OF THE RETURNED SUBJECT COIL, THE PROXIMAL END OF THE SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE KINKED/BENT AND THE MAIN COIL WAS FOUND TO BE STRETCHED AND BROKEN/FRACTURED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139768 ↗
• MalfunctionJan 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL ENCOUNTERED STRONG RESISTANCE AT THE HUB OF THE MICROCATHETER. IT WAS REPLACED WITH ANOTHER COIL, BUT RESISTANCE WAS ALSO NOTED WITH THIS COIL. THE COIL WAS REPLACED THE THIRD TIME BUT IT STILL COULD NOT BE ADVANCED INSIDE THE CATHETER. UPON REMOVAL, THE PHYSICIAN CONFIRMED THAT THE SUBJECT COIL WAS PREMATURELY DEPLOYED INSIDE THE MICROCATHETER AND WAS STRETCHED AT THE PROXIMAL SECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL ENCOUNTERED STRONG RESISTANCE AT THE HUB OF THE MICROCATHETER. UPON REMOVAL, IT WAS CONFIRMED THAT THE SUBJECT COIL WAS PREMATURELY DEPLOYED INSIDE THE MICROCATHETER AND WAS STRETCHED AT THE PROXIMAL SECTION. IT WAS REPLACED WITH ANOTHER COIL, BUT RESISTANCE WAS ALSO NOTED WITH THIS COIL. THE COIL WAS REPLACED FOR THE THIRD TIME, BUT STILL IT COULD NOT BE ADVANCED INSIDE THE CATHETER. 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 13333684 ↗
• InjuryDec 1, 2021Expulsion; Expulsion

  DURING ONE MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM EMBOLIZATION CASE, THE OPERATOR PLACED THE MICROCATHETER TO THE CHILD LUMEN OF ANEURYSM AND THEN INSERTED A SUBJECT COIL. HOWEVER, AFTER DETACHED THE SUBJECT COIL, THE OPERATOR PULLED THE MICROCATHETER TO THE PARENT LUMEN OF ANEURYSM AND DURING THIS PROCESS THE SUBJECT COIL STICK TO THE MICROCATHETER WHICH LED TO PART OF THE SUBJECT COIL WAS BROUGHT INTO THE VESSEL. THE OPERATOR TRIED TO DELIVER A GUIDEWIRE THROUGH MICROCATHETER TO PUSH THE SUBJECT COIL WHICH WAS IN THE VESSEL TO DISTAL BUT FAILED AND CAUSED THE SURGICAL DELAY. ANOTHER MICROCATHETER WAS USED THEN PLACED TO LOWER OF MCA AND DEPLOYED A STENT TO PRESS THE COIL TO THE VESSEL WALL. THEN CONTINUED THE EMBOLIZATION AND FINISHED THE PROCEDURE WITH ANOTHER STENT DEPLOYED TO ASSIST. AFTER THE PROCEDURE IS COMPLETED, THE PATIENT EXPERIENCED WITH SLEEPINESS. PER PHYSICIAN¿S OPINION, THE SLEEPINESS WAS CAUSED BY THE SUBJECT COIL PROTRUDING INTO THE BLOOD VESSEL AFFECTS BLOOD FLOW. THE PATIENT IS CURRENTLY TRANSFERRED TO ANOTHER HOSPITAL AND IS NOT CLEAR ABOUT THE CURRENT SITUATION .

  Patient problems: Sleep Dysfunction

  MAUDE report 12912480 ↗
• MalfunctionSep 8, 2021Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442298 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE INZONE DETACHMENT DEVICE WAS USED TO DETACH THE SUBJECT COIL. WHEN THE INZONE DETACHMENT DEVICE INDICATED 3 BEEPS TO DETACH, THE SUBJECT COIL COULD NOT BE DETACHED BUT ONE LOOP OF THE SUBJECT COIL WENT OUT INTO THE VESSEL AND OTHER SIDE OF THE SUBJECT COIL STUCK IN THE DISTAL END OF THE MICROCATHETER RESULTING SURGICAL DELAY. FINALLY, THE SUBJECT COIL HAS BEEN DETACHED AND COMPLETED THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. UPDATE: FURTHER REVIEWING THE EVENT, THERE WAS NO ISSUE WITH DETACHMENT BUT SEEMS THE COIL REMAINED STUCK IN THE DISTAL OF THE MICROCATHETER AFTER DETACHMENT. ADDITIONAL INFORMATION WAS CAPTURED ON 10-DECEMBER THAT THE PATIENT IS STILL AT THE HOSPITAL WITH HEMIPARESIS AND SEVERE DYSPHASIA. THE PATIENT¿S CURRENT CONDITION IS HEMODYNAMICALLY STABLE, GOOD CLINICAL EVOLUTION. REMAINS APHASIC PERSISTS WITH RIGHT HEMIPARESIS, IMPROVEMENT OF RIGHT LOWER LIMB TONE IS EVIDENCED.

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375224 ↗
• MalfunctionAug 6, 2021Fracture; Fracture

  IT WAS REPORTED DURING THE RIGHT MCA ANEURYSM PROCEDURE, A GUIDE WIRE WAS USED TO BRING THE MICROCATHETER TO THE 1/3 OF THE ANEURYSM AND FRAMED IT WITH THE COIL. PHYSICIAN CHOSE THE SUBJECT COIL TO FILL THE ANEURYSM, BUT IT WAS HARD TO BE DELIVERED INTO THE MICROCATHETER. ON WITHDRAWAL, TIP OF THE SUBJECT COIL WAS FOUND BROKEN. 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 12288084 ↗
• MalfunctionJun 19, 2021Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029637 ↗
• MalfunctionMay 18, 2021Premature Separation; Premature Separation

  IT WAS INITIALLY REPORTED DURING MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM PROCEDURE, THE COIL (SUBJECT DEVICE) EXPERIENCE RESISTANCE WHEN ADVANCING INTO THE MICROCATHETER TIP. THE OPERATOR USED ANOTHER COIL TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844816 ↗
• MalfunctionMay 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT ENDOVASCULAR ANEURYSMAL COIL EMBOLIZATION PROCEDURE WAS PERFORMED. AFTER ADVANCEMENT OF THE TARGET COIL TO THE ANEURYSM, THE SUBJECT COIL WAS TRIED TO DETACH USING DETACHMENT SYSTEM. THOUGH THE DETACHMENT SYSTEM KEPT IN THE STABLE POSITION AND PLACEMENT OF MARKER WAS CHECKED, EVEN AFTER THREE SUCCESSFUL ATTEMPTS TO DETACH THE SUBJECT COIL BY DETACHMENT SYSTEM, IT WAS UNABLE TO DETACH. THE MOVEMENT OF COIL WAS CHECKED UNDER FLUOROSCOPY WHEN DETACHMENT WAS PERFORMED. THE DISTAL PORTION OF SUBJECT COIL DELIVERY WIRE WAS TORN OFF/FRACTURED WHEN TRYING TO ADVANCE THE DELIVERY WIRE FOR REPOSITIONING OF IT INTO THE DESIRED ANEURYSMAL SITE. THE PHYSICIAN WAS ABLE TO REMOVE ALL PARTS OF TORN DELIVERY WIRE FROM PATIENT ANATOMY. 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 11822880 ↗
• InjuryMar 27, 2021Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE GUIDEWIRE WAS INSERTED TO REMOVE THE CATHETER, THE PROXIMAL PART OF THE PREVIOUSLY DETACHED COIL (SUBJECT DEVICE) STUCK TO THE TIP OF THE CATHETER. AN ATTEMPT WAS MADE TO RELEASE THE SUBJECT COIL FROM THE CATHETER WITH A GUIDING CATHETER UNSUCCESSFULLY. THE SUBJECT COIL MIGRATED FROM INSIDE THE ANEURYSM, CAME OFF THE CATHETER TIP AND BECAME ENTANGLED WITH A PREVIOUSLY PLACED STENT. THE SUBJECT COIL WAS THEN SUCCESSFULLY REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579615 ↗
• MalfunctionMar 25, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED FROM THE PUSHER WIRE AND THE PROXIMAL END OF THE SUBJECT COIL WAS STILL WITHIN THE MICROCATHETER (SNAGGED WITH TIP) AND THE SUBJECT COIL WOULD NOT COME OUT. THE MICROCATHETER AND THE SUBJECT COIL WERE REMOVED, AND THE NEW MICROCATHETER AND COIL WERE USED TO COMPLETE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571862 ↗
• MalfunctionFeb 16, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS USED, THE PHYSICIAN WAS ABLE TO PACK AND DETACH THE SUBJECT COIL AT TARGET LOCATION. HOWEVER UPON ATTEMPTING TO REMOVE THE CATHETER, THE SUBJECT COIL WAS STUCK AT THE CATHETER TIP AFTER ITS DETACHMENT. THE PHYSICIAN WAS NOT ABLE TO REMOVE THE STUCK SUBJECT COIL UPON MULTIPLE REMOVAL ATTEMPTS. WHEN THE PHYSICIAN PULLED THE WHOLE CATHETER BACK, THE SUBJECT COIL CAME OUT IN A ROW. 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 11334977 ↗