TARGET M0036180640Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327466409), received between Jan 28, 2020 and Sep 18, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Premature Separation

  It was initially reported that during introduction, the subject coil device became stuck within the microcatheter. Subsequent analysis of the returned coil device revealed that it had prematurely detached during use. The subject coil was replaced with a new device, and the procedure was completed successfully with no reported clinical consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813662 ↗
• MalfunctionMar 30, 2026Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE FOR THE GASTRIC VARICES, WHEN ADVANCING THE SUBJECT COIL WITHIN THE MICROCATHETER, STRONG RESISTANCE WAS ENCOUNTERED IN THE SHAFT, AND GOT STUCK. WHEN RETRACTING THE SUBJECT COIL, IT GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER SHAFT. 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 24718957 ↗
• MalfunctionJan 8, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE RENAL ARTERIOVENOUS MALFORMATION (AM) PROCEDURE. WHILE COILING IN THE ANEURYSM, THE SUBJECT COIL GOT PREMATURELY DETACHED IN THE VESSEL. 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 24016209 ↗
• MalfunctionJan 8, 2026Premature Separation

  IT WAS REPORTED THAT DURING THE RENAL ARTERIOVENOUS MALFORMATION (AM) PROCEDURE. WHILE COILING IN THE ANEURYSM, THE SUBJECT COIL GOT PREMATURELY DETACHED IN THE VESSEL. 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 24015943 ↗
• MalfunctionDec 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE SPLENIC ARTERY ANEURYSM EMBOLIZATION, THE SUBJECT COIL ENCOUNTERED RESISTANCE WHEN IT WAS ABOUT TO BE ADVANCED FROM THE DISTAL TIP OF THE MICROCATHETER. WHILE RETRACTING, THE SUBJECT COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER SHAFT. 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 23700808 ↗
• MalfunctionMay 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING GASTRODUODENAL ARTERY COIL EMBOLIZATION CASE, THE SUBJECT COIL WAS ABLE TO MOVE WITH THE RESISTANCE AND WAS PREMATURELY DETACHED IN THE MICROCATHETER SHAFT. THE SUBJECT COIL 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 22058057 ↗
• MalfunctionJan 31, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS USED FOR THE PURPOSE OF HEPATIC VEIN EMBOLIZATION, AND IT WAS INSERTED INTO THE MICROCATHETER. WHEN THE SUBJECT COIL WAS DEPLOYED IN THE BLOOD VESSEL AND IT WAS REPOSITIONED TO ENGAGE WITH THE VESSEL, RESISTANCE OCCURRED, AND THE COIL BECAME PREMATURELY DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM THE PATIENT. THE SUBJECT COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286901 ↗
• MalfunctionJul 31, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS PUT OUT INTO THE ANEURYSM AND ONCE RETRIEVED THE SUBJECT COIL DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE MICROCATHETER AND SUBJECT COIL WERE REMOVED. THE SUBJECT COIL 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 19877836 ↗
• InjuryDec 18, 2023Fracture; Migration; Premature Separation; Fracture; Migration; Premature Separation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, WHEN THE SUBJECT COIL WAS BEING IMPLANTED IN THE ANEURYSM. IT WAS STRETCHED AT THE DISTAL END AND WAS UNABLE TO BE RETRACTED OUT. THE SUBJECT COIL WAS MIGRATING TO THE PARENT VESSEL. IT WAS DECIDED TO REMOVE THE SUBJECT COIL, WHILE ATTEMPTING TO RETRIEVE IT FROM THE VESSEL, IT GOT PREMATURELY DETACHED. THE PHYSICIAN THEN TRIED TO USE A SNARE DEVICE TO REMOVE THE DETACHED COIL, BUT IT GOT FRACTURED DURING THE PROCESS. AS A RESULT, IT WAS DECIDED TO LEAVE IT INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18343944 ↗
• MalfunctionMar 9, 2023Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED/SEPARATED 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 16518369 ↗
• MalfunctionFeb 17, 2023Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE 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 16401199 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS OBSERVED WHEN THE COIL (SUBJECT DEVICE) WAS BEING ADVANCED WITHIN A MICROCATHETER AND IT WAS STRETCHED DURING RETRIEVAL. THE COIL (SUBJECT DEVICE) WAS FOUND TO BE BROKEN INSIDE MICROCATHETER DURING REMOVAL. 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 15505915 ↗
• MalfunctionAug 23, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL WAS PREMATURELY DETACHED DURING USE. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356445 ↗
• MalfunctionApr 13, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE ENTIRE MICROCATHETER WAS REMOVED AND THE DETACHED SUBJECT COIL WAS COLLECTED ALONG WITH IT. 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 11662462 ↗
• InjuryJan 15, 2021Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY DURING THE PROCEDURE AND WAS REMOVED FROM THE PATIENT'S ANATOMY USING A SNARE DEVICE. 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 11180352 ↗
• MalfunctionSep 17, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN TRIED TO DETACH THE COIL USING THE DETACHMENT SYSTEM BUT WAS UNABLE TO DO SO. HE ATTEMPTED TO REMOVE THE COIL BUT ON DOING SO THE COIL DETACHED PREMATURELY INSIDE THE MICRO 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 10551685 ↗
• MalfunctionJan 28, 2020Premature Separation; Premature Separation

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE MAIN COIL PREMATURELY DETACHED INSIDE PATIENT. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639322 ↗