TARGET M0035431020Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04546540698001), received between Oct 31, 2016 and Apr 6, 2026 — classified as 7 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (13 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHILE ADVANCING THE SUBJECT DEVICE THROUGH THE MICROCATHETER RESISTANCE WAS ENCOUNTERED, THE SUBJECT COIL WAS STRETCHED AND GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE SUBJECT DEVICE WAS RETRIEVED AND REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796202 ↗
• MalfunctionMay 6, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT IT HAD PREMATURELY DETACHED 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 21973438 ↗
• MalfunctionNov 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING PCA (POSTERIOR CEREBRAL ARTERY) BIFURCATION ANEURYSM, WHEN DELIVERING THE SUBJECT COIL DEVICE FROM INTRODUCING SHEATH TO GO INTO MICROCATHETER, THE RESISTANCE WAS ENCOUNTERED BUT THE SUBJECT COIL WAS STILL ABLE TO BE ADVANCED. HOWEVER, WHEN THE SUBJECT COIL REACHED TO THE DISTAL OF THE MICROCATHETER, IT GOT STUCK COMPLETELY. THEREFORE, THE SUBJECT COIL WAS WITHDRAWN FROM THE PATIENT, AND THE SUBJECT COIL WAS FRACTURED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716560 ↗
• MalfunctionJun 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING MIDDLE CAROTID ARTERY (MCA) ANEURYSM EMBOLIZATION PROCEDURE, THE OPERATOR USED THE SUBJECT COIL TO DELIVER INTO THE MICROCATHETER. THE OPERATOR CHECKED THE DEVICE AND FLUSHED IT BEFORE DELIVERY, HOWEVER, BIG RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY AND THE SUBJECT COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. WHEN THE OPERATOR WITHDREW THE COIL, HE FOUND THAT IT WAS FRACTURED FROM THE 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 19462936 ↗
• InjuryMar 15, 2024Expulsion; Expulsion

  IT WAS REPORTED THAT DURING STENT ASSISTED COIL EMBOLIZATION CASE, THE OPERATOR DEPLOYED THE STENT AND THEN USED A MICROCATHETER TO DELIVER TWO COILS. WHEN THE SUBJECT COIL WAS USED TO FINISH THE PROCEDURE, THE RESISTANCE WAS ENCOUNTERED DURING ITS DELIVERY. WHEN THE SUBJECT COIL WAS PLACED TO THE LOCATION, THE OPERATOR TRIED TO DETACH IT. THE POWER SUPPLY SHOWED SUCCESSFUL DETACHMENT AND THE OPERATOR RETRACTED THE MICROCATHETER. HOWEVER, THE TAIL OF THE SUBJECT COIL WENT OUT TOGETHER WITH THE MICROCATHETER. THUS, IT WAS CONCLUDED THAT THE SUBJECT COIL WAS NOT DETACHED SUCCESSFULLY. THE OPERATOR USED THE STENT DELIVERY WIRE AS A MEDICAL INTERVENTION TO SEPARATE THE SUBJECT COIL FROM THE MICROCATHETER. THE SUBJECT COIL WAS SEPARATED BUT PART OF IT PROTRUDED FROM THE ANEURYSM. 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 18914492 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  IT WAS REPORTED THAT DURING ANTERIOR COMMUNICATING ARTERY (ACOMA) ANEURYSM PROCEDURE, THE OPERATOR USED THE GUIDEWIRE TO BRING THE MICROCATHETER TO THE ANEURYSM. NEXT THE OPERATOR PREPARED AND PLACED THE SUBJECT COIL TO THE LOCATION. THE OPERATOR DETACHED THE COIL AND WITHDREW THE DELIVERY WIRE OUT. HOWEVER, WHEN THE OPERATOR TRIED TO WITHDRAW THE MICROCATHETER HE FOUND THAT THE PROXIMAL OF THE SUBJECT COIL ADHERED TO THE TIP OF THE MICROCATHETER. THE OPERATOR USED THE GUIDEWIRE TO PUSH THE COIL OUT BUT UNSUCCESSFULLY. THE OPERATOR WITHDREW THE MICROCATHETER AND THE SUBJECT COIL OUT TOGETHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 14-FEB-2024 STATED THAT THE SUBJECT COIL WAS NOT PREMATURELY DETACHED DURING USE. IT WAS DETACHED NORMALLY AND THEN BECAUSE OF THE REPORTED ISSUE IT WAS TAKEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664506 ↗
• MalfunctionJul 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM CASE, THE PHYSICIAN USED A MICROCATHETER AND GUIDEWIRE TO BUILD ACCESS AND INSERTED 3 COILS BEFORE PREPARING TO INSERT THE SUBJECT COIL. WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE SUBJECT COIL AND THE POWER SUPPLY INDICATOR LIT UP, THE DELIVERY WIRE WAS RETRACTED UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) BUT THE PHYSICIAN FOUND THE SUBJECT COIL DID NOT DETACH. AFTER READJUSTING THE POSITION OF THE SUBJECT COIL, A SECOND ATTEMPT WAS MADE TO DETACH THE DEVICE BUT THE SUBJECT COIL DID NOT DETACH. THE PHYSICIAN PULLED THE SUBJECT COIL BACK INTO THE MICROCATHETER AND IT FRACTURED AT THE DETACHMENT POINT AND DETACHED UNEXPECTEDLY. THE SUBJECT COIL AND MICROCATHETER WERE WITHDRAWN TOGETHER AND INSPECTED. THE SUBJECT COIL COULD NOT BE REMOVED FROM THE MICROCATHETER WITH A GUIDEWIRE. THE DELIVERY WIRE WAS INSPECTED AND IT WAS FOUND THAT THE DETACHMENT POINT HAD SOME COIL PRIMARY WIND STILL ATTACHED AFTER THE SUBJECT COIL STRETCHED. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351170 ↗
• MalfunctionApr 28, 2023Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS 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 16839616 ↗
• MalfunctionApr 26, 2023Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED SUBJECT COIL REVEALED THAT IT PREMATURELY DETACHED DURING USE. 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 16817249 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR INVESTIGATION AND IT WAS DISCOVERED THAT THE COIL HAD 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 16444954 ↗
• MalfunctionMay 23, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS DETACHED PREMATURELY DURING USE. 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 14475618 ↗
• InjuryOct 28, 2021Expulsion; Expulsion

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN DETACHED THE SUBJECT COIL INTO THE ANEURYSM. ON WITHDRAW THE MICROCATHETER, THE SUBJECT COIL WAS FOUND STUCK AT THE DISTAL TIP OF THE MICROCATHETER AND PROTRUDE INTO THE PARENT VESSEL. THE PHYSICIAN DEPLOYED STENT AS MEDICAL INTERVENTION TO SECURE THE COIL MASS. HOWEVER, A THROMBUS WAS GENERATED SO TIROFIBAN HALF AMPLE IS GIVEN TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12716825 ↗
• MalfunctionFeb 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE PHYSICIAN WAS UNABLE TO DELIVER THE SUBJECT COIL OUT OF THE MICRO CATHETER. DURING THE ATTEMPT TO REMOVE THE SUBJECT COIL FROM THE PATIENT¿S ANATOMY, IT PREMATURELY DETACHED INSIDE THE MICRO CATHETER. THE MICRO CATHETER WAS WITHDRAWN FROM THE PATIENT¿S ANATOMY AND THE DETACHED SUBJECT COIL WAS REMOVED ALONG WITH IT. 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 11349738 ↗
• MalfunctionFeb 19, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE PHYSICIAN WAS UNABLE TO DELIVER THE SUBJECT COIL OUT OF THE MICRO CATHETER. DURING THE ATTEMPT TO REMOVE THE SUBJECT COIL FROM THE PATIENT¿S ANATOMY, IT PREMATURELY DETACHED INSIDE THE MICRO CATHETER. THE MICRO CATHETER WAS WITHDRAWN FROM THE PATIENT¿S ANATOMY AND THE DETACHED SUBJECT COIL WAS REMOVED ALONG WITH IT. 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 11349725 ↗
• MalfunctionFeb 3, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT COIL IN THE MICRO CATHETER AND IT GOT STUCK IN THE DISTAL PORTION OF THE MICRO CATHETER. THE PHYSICIAN WORRIED THAT THE SUBJECT COIL MIGHT STRETCH DURING MULTIPLE ADJUSTMENTS, RETRACTED IT AND REPLACED IT WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE MAIN COIL PREMATURELY DETACHED/SEPARATED 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 11276939 ↗
• MalfunctionNov 23, 2020Premature Separation; Premature Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10887079 ↗
• MalfunctionOct 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE DELIVERING THE SUBJECT COIL IN A MICROCATHETER. RESISTANCE WAS ENCOUNTERED BEFORE THE SUBJECT COIL REACHED THE MICROCATHETER TIP AND IT WAS UNABLE TO BE ADVANCED ANY MORE. AFTER SEVERAL UNSUCCESSFUL TRIES THE PHYSICIAN WITHDREW THE SUBJECT COIL AND REPLACED IT WITH ANOTHER DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL HAD BROKEN/FRACTURED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731146 ↗
• MalfunctionJul 16, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE THE SUBJECT COIL WAS DELIVERED TO THE END OF THE MICROCATHETER THE OPERATOR FELT RESISTANCE AND WAS UNABLE TO DEPLOY THE SUBJECT COIL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE DEVICE REVEALED THAT THE MAIN COIL HAD PREMATURELY DEPLOYED; THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND EMDR WILL BE FILED WITH AN AWARE DATE OF 16-JUL-2020. THE EVENT WILL BE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.

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

  MAUDE report 10285607 ↗
• MalfunctionMay 20, 2020Fracture; Premature Separation; Fracture; Premature Separation

  IT WAS REPORTED DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE SUBJECT DEVICE COIL WAS DELIVERED INTO THE POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM OF THE LEFT SIDE AND DETACHED NORMALLY. WHEN WITHDREW THE DELIVERY GUIDEWIRE, THE OPERATOR FOUND THAT THE SUBJECT COIL WAS NOT DETACHED COMPLETELY. THE DISTAL PART OF THE SUBJECT COIL WAS IN THE ANEURYSM AND THE PROXIMAL PART WAS IN MICROCATHETER. THE OPERATOR TRIED TO PUSH THE SUBJECT COIL AGAIN BUT FOUND THE DELIVERY WIRE AND THE SUBJECT COIL WAS SEPARATED. THEREFORE, THE OPERATOR WITHDREW THE DELIVERY WIRE AND PREPARED TO ADVANCE A WIRE TO HELP TO PUSH THE SUBJECT COIL, BUT AFTER SEVERAL TRIES THE COIL COULDN'T BE FILLED SO FINALLY WITHDREW IT TOGETHER WITH THE MICORCATHETER AND FINISHED THE PROCEDURE. ACCORDING TO THE PHYSICIAN THAT THE SUBJECT COIL WAS STRETCHED SO IT COULDN¿T BE DETACHED COMPLETELY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075480 ↗
• MalfunctionMar 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL COULD NOT BE FULLY DETACHED. UPON REMOVAL OF THE SUBJECT COIL, IT HAD APPEARED THAT THE COIL HAD FRACTURED AND WAS RETRIEVED BY THE MICROCATHETER USED DURING THE PROCEDURE. THE PHYSICIAN THEN REPLACED THE SUBJECT COIL AND THE MICROCATHETER AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866834 ↗
• MalfunctionJan 28, 2020Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DELIVERY WIRE OF THE SUBJECT COIL WAS FOUND BROKEN/FRACTURED INSIDE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639844 ↗
• MalfunctionSep 20, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL DELIVERY WIRE HAD BROKEN INSIDE THE PATIENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9101035 ↗
• MalfunctionJan 3, 2019Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE MAIN COIL WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8215489 ↗
• MalfunctionNov 21, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, FRICTION WAS OBSERVED IN THE CATHETER LUMEN AND WHEN PHYSICIAN TRIED TO PULL OUT THE SUBJECT COIL, IT DETACHED UNINTENTIONALLY IN THE MICROCATHETER. THE DETACHED COIL COULD NOT BE LOCATED UNDER FLUOROSCOPY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097271 ↗
• MalfunctionAug 31, 2018Break; Break

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL (SUBJECT DEVICE) EXPERIENCED RESISTANCE DURING INSERTION INTO MICROCATHETER AND UPON REMOVAL, THE COIL DELIVERY WIRE BROKE. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838732 ↗