TARGET M0035424150Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04546540675941), received between Apr 27, 2017 and Jul 30, 2026 — classified as 1 death, 4 injuries, 20 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086818 ↗
• MalfunctionFeb 3, 2026Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS FRACTURED. 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 24243249 ↗
• InjuryNov 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING THE COIL EMBOLIZATION OF ANTERIOR COMMUNICATING ARTERY (ACOMA) RUPTURED ANEURYSM. THE SUBJECT COIL GOT PREMATURELY DETACHED AND MADE THE MICROCATHETER OUT OF CONTROL AND REMAINED ABOUT 10 CM IN THE MICROCATHETER. THE SUBJECT COIL WAS THEN PUSHED OUT OF MICROCATHETER USING A GUIDEWIRE AND A STENT WAS USED TO PUSH THE SUBJECT COIL UP INTO THE ANEURYSM. THERE WAS A SURGICAL DELAY OF 60 MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578443 ↗
• MalfunctionJan 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE IT WAS IMPOSSIBLE TO PASS THE SUBJECT COIL THROUGH A MICROCATHETER AND THE SUBJECT COIL CURLED AND DISINTEGRATED INSIDE THE MICROCATHETER DURING THE PROCEDURE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. A SURGICAL DELAY OF UNKNOWN LENGTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150414 ↗
• MalfunctionDec 12, 2023Premature Separation; Premature Separation

  IT WAS REPORTED, DURING THE PROCEDURE. WHEN THE PHYSICIAN WAS PLACING THE LAST LOOP OF THE SUBJECT COIL INTO THE ANEURYSM, IT PREMATURELY DETACHED. 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 18311655 ↗
• MalfunctionAug 24, 2023Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) DETACHED/SEPARATED DURING USE. 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 17611693 ↗
• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL PREMATURELY DETACHED/SEPARATED 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 17235994 ↗
• DeathMar 8, 2023Fracture; Expulsion; Premature Separation; Fracture; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING ACOM LARGE NECK RUPTURED ANEURYSM PROCEDURE, AFTER THE PHYSICIAN PUT THE COIL (SUBJECT DEVICE), HE NOTICED THAT IT WAS TOO LONG SO DECIDED TO REMOVE IT. DURING WITHDRAWAL THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED AND THE PUSHER WAS BROKEN IN TWO PIECES (FROM THE RADIOPAQUE MARKET PROXIMALLY WAS IN HIS HAND, AND THE DISTAL PORTION OF THE PUSHER WAS IN THE ARTERY). THE COIL (SUBJECT DEVICE) WAS THE MAJORITY IN THE ANEURYSM, 2CM IN A1 AND THE REMAINING PART OF THE PUSHER IN A1-SYPHON. THE PHYSICIAN TRIED TO REMOVE WITH A LAZZOO WITHOUT SUCCESS. THERE WAS A SURGICAL DELAY OF UNKNOWN DURATION. ADDITIONAL INFORMATION RECEIVED ON 02- MAR-2023 INCLUDED THAT PATIENT PASSED AWAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16507952 ↗
• InjuryMar 8, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED DURING THE PROCEDURE TO TREAT A RIGHT ICA-OA (INTERNAL CAROTID ARTERY) BIFURATION ANEURYSM, WHEN HALF OF THE SUBJECT COIL WAS PLACED IN THE ANEURYSM, THE OTHER HALF STRETCHED AND PROTRUDED OUT OF THE ANEURYSM. THE PHYSICIAN USED A STENT DEVICE AS A SNARE TO PRESS THE STRETCHED COIL IN THE VESSEL. THE REMAINING PART OF THE STRETCHED COIL WAS LEFT INSIDE OF THE PATIENT¿S VESSEL FROM THE INTRACRANIAL POSITION TO THE PUNCTURE SITE. AFTER IT WAS TAKEN OUT, THE PHYSICIAN CUT THE REMAINING STRETCHED SEGMENT AT THE PUNCTURE POINT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16504134 ↗
• MalfunctionNov 28, 2022Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874292 ↗
• MalfunctionMay 7, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. 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 14317882 ↗
• MalfunctionApr 25, 2022Fracture; Fracture

  IT WAS INITIALLY REPORTED THAT DURING ACOMA ANEURYSM STENT ASSISTED EMBOLIZATION CASE. AFTER PLACING THE MICROCATHETER TO THE LESION, USED THE SUBJECT COIL TO FRAME. DURING THIS PROCEDURE, THE SHAPE OF THE FRAMING WAS NOT GOOD ENOUGH SO THE WITHDREW THE SUBJECT COIL OUT AND DURING THIS PROCEDURE, THE SUBJECT COIL KINKED AT DISTAL OF MICROCATHETER AND COULD NOT BE RETRACTED INTO MICROCATHETER AND NOT ABLE TO BE ADVANCED OUT EITHER. THEREFORE, THE OPERATOR WITHDREW THE SYSTEM AND TOOK THE SUBJECT COIL OUT FROM TIP OF THE MICROCATHETER AND THEN USED ANOTHER COIL IN SAME CATALOG TO FRAME SUCCESSFULLY. THEN PREPARED TO DEPLOY A STENT STENT BUT WHEN IT WAS DELIVERED INTO SL-10, THE STENT COULD NOT BE ADVANCED INTO HUB OF MICROCATHETER EVEN AFTER SEVERAL ADJUSTMENTS. THE MICROCATHETER WAS REPLACED WITH A NEW ONE TO TRY BUT THE STENT WAS STILL NOT ABLE TO BE PUSHED INTO MICROCATHETER. FINALLY REPLACED THE STENT WITH ANOTHER ONE IN SAME CATALOG TO FINISH THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT COIL DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196854 ↗
• InjuryMar 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT A RIGHT PCOMA (POSTERIOR COMMUNICATING ARTERY) ANEURYSM EMBOLIZATION PROCEDURE WAS PERFORMED IN A FEMALE PATIENT WITH RIGHT PCOMA (POSTERIOR COMMUNICATING ARTERY) DISSECTION ANEURYSM. DURING THE PROCEDURE THE PHYSICIAN USED A GUIDEWIRE TO BRING A MICROCATHETER TO REACH THE ANEURYSM AND PREPARED TO FILL THE SUBJECT COIL. AFTER DELIVERED HALF OF THE SUBJECT COIL INTO ANEURYSM, THE SUBJECT COIL WAS NOT ABLE TO BE ADVANCED ANY MORE. THE PHYSICIAN THEN TRIED TO RETRACT THE SUBJECT COIL DELIVERY WIRE, BUT FOUND THE SUBJECT COIL GOT FRACTURED AND PART OF THE SUBJECT COIL WAS INSIDE THE PATIENT'S VASCULAR ANATOMY. THE PHYSICIAN SHAPED A GUIDEWIRE AND USED THE GUIDEWIRE AS A SNARE DEVICE TO RETRIEVE THE SUBJECT COIL OUT BY ENTWINING THE SUBJECT COIL WITH THE SHAPED GUIDEWIRE. WHEN THE PHYSICIAN DELIVERED THE GUIDEWIRE INTO PATIENT'S BODY FOR SEVERAL MINUTES AND CHECKED UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE GUIDEWIRE TIP WAS NOT MOVED AND WHEN WITHDREW THE GUIDEWIRE, THE PHYSICIAN FOUND THAT THE GUIDEWIRE WAS FRACTURED AND WAS LEFT INSIDE PATIENT'S VASCULAR ANATOMY. FINALLY, THE PHYSICIAN DECIDED TO PERFORM A CRANIOTOMY PROCEDURE TO TAKE THE FRACTURED COIL OUT AND U

  Patient problems: Coma

  MAUDE report 13831806 ↗
• MalfunctionAug 28, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER DURING INSERTION INTO THE ANEURYSM. PART OF THE COIL WAS OUT OF THE MICROCATHETER, AND WHEN THE PHYSICIAN TRIED TO PULL BACK THE DELIVERY WIRE, THE MAIN COIL COULD NOT BE RETRACTED BACK INTO THE MICROCATHETER. THE PHYSICIAN ENDED THE ENDOVASCULAR ATTEMPT AND PULLED ALL THE DEVICES TOGETHER OUT OF THE PATIENT¿S ANATOMY. ON THE BACK TABLE, IT WAS DISCOVERED THAT THE COIL HAD DETACHED PREMATURELY. THE PATIENT IS DOING FINE AND GOING TO THE SURGERY FOR CLIPPING DUE TO THE ANATOMY NOT BEING AMENDABLE TO ENDOVASCULAR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381307 ↗
• MalfunctionMar 16, 2021Premature Separation; Premature Separation

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL PREMATURELY DETACHED 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 11498805 ↗
• MalfunctionMar 2, 2021Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS ON (B)(6) 2021 AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL WAS BROKEN DURING THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401771 ↗
• MalfunctionFeb 1, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL ENCOUNTERED DIFFICULTY WHILE BEING PUSHED AND PULLED IN THE MICROCATHETER AND WAS FOUND TO HAVE DETACHED PREMATURELY. THE PHYSICIAN TRIED TO REMOVE THE SUBJECT COIL FROM THE MICROCATHETER, BUT IT GOT STUCK AT THE CATHETER TIP. PHYSICIAN REMOVED THE ENTIRE CATHETER AND COIL FROM THE PATIENT ANATOMY. ATTEMPTS TO REMOVE THE SUBJECT COIL FROM THE CATHETER OUTSIDE THE PATIENT¿S BODY WERE STILL UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263666 ↗
• MalfunctionOct 29, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED INSIDE THE 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 10753389 ↗
• MalfunctionSep 10, 2019Break; Break

  DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE PROXIMAL DETACH AREA ON COIL DELIVERY WIRE WAS BROKEN DURING THE DELIVERY AND THE COIL COULDN'T BE ADVANCED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CHANGING THE DEVICE AND THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984835 ↗
• MalfunctionJun 28, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THE COIL PREMATURELY DEPLOYED IN THE MICROCATHETER; THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746460 ↗
• InjuryMar 7, 2019Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED DURING COIL EMBOLIZATION PROCEDURE FOR ANEURYSM WITH DIAMETER OF 5.2MM AND LENGTH OF 8MM, LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) C6. THE SUBJECT WAS INSERTED SUCCESSFULLY; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO DETACH THE COIL. THE SUBJECT COIL WAS ENTANGLED WITH THE COIL MASS INSIDE THE ANEURYSM; THEREFORE, THE PHYSICIAN WAS NOT ABLE TO WITHDRAW THE COIL FROM THE PATIENT¿S ANATOMY. THE SUBJECT COIL WAS ROTATED AND BROKEN. THE BROKEN COIL WAS PROTRUDED ABOUT 1 CM FROM THE ANEURYSM INTO THE PARENT VESSEL. THE REST OF THE COIL WAS PULLED OUT OF THE PATIENT¿S ANATOMY AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAS LEFT THE HOSPITAL AND BEEN IN A GOOD CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8402163 ↗
• MalfunctionJan 29, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION RETREATMENT, ANGIOGRAPHY REVEALED THAT THE 6TH COIL (SUBJECT DEVICE) WAS HERNIATED OUT OF THE ANEURYSM NECK AND PARTIALLY INTO THE VESSEL LUMEN. SUBSEQUENT ANGIOGRAPHY DEMONSTRATED NO EVIDENCE OF THROMBUS FORMATION ON THE COIL LOOP. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286380 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT PRIOR THE SUBJECT COIL EMBOLIZATION PROCEDURE OF THE MIDDLE CEREBRAL ARTERY (MCA), IT WAS FOUND THAT THE DISTAL OF POSITION WHICH WAS NEAR THE SHAFT PROXIMAL WAS FRACTURED. THE FRACTURED PARTS WERE STILL CONNECTED AT THAT TIME. SO, THE OPERATOR REPLACED THE SUBJECT COIL WITH ANOTHER ONE IN SAME TYPE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270828 ↗
• MalfunctionJun 27, 2018Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS INSERTED INTO THE CATHETER; HOWEVER, THE COIL GOT STUCK NEAR THE MICROCATHETER HUB. THE PHYSICIAN REMOVED THE COIL AND WHEN TRIED TO ADVANCE THE COIL FOR THE SECOND TIME THROUGH THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. THE COIL WAS REMOVED AND BROKEN COIL WAS OBSERVED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641160 ↗
• MalfunctionApr 27, 2017Premature Activation; Premature Activation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE MAIN COIL WAS MECHANICALLY DETACHED FROM THE DELIVERY WIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6527227 ↗