TARGET M0036180520Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327466379), received between Dec 10, 2019 and Sep 12, 2025 — classified as 4 injuries, 10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE GASTRIC VEIN COIL EMBOLIZATION PROCEDURE, THE SUBJECT COIL DETACHED IN THE MICROCATHETER. THE GUIDEWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038472 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE ANEURYSM COILING PROCEDURE THERE WAS RESISTANCE WHILE REPOSITIONING THE SUBJECT COIL AT THE TARGET SITE TO ENGAGE WITH THE VESSEL. WHILE REPOSITIONING, THE SUBJECT COIL WAS STRETCHED. A SNARE DEVICE WAS USED TO REMOVE IT. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332611 ↗
• MalfunctionMar 8, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING SPLENIC ARTERY ANEURYSM PROCEDURE THE PHYSICIAN TRIED TO REPOSITION THE FOURTEENTH COIL (SUBJECT DEVICE) TWICE TO ENGAGE IN THE ANEURYSM, BUT THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED. THE COIL (SUBJECT DEVICE) WAS REMOVED WITH THE ENTIRE 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 16506846 ↗
• MalfunctionOct 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, WHEN THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER IT GOT DETACHED PREMATURELY WITHIN THE CATHETER. THE SUBJECT COIL WAS REMOVED ALONG WITH THE CATHETER. THE PHYSICIAN REPLACED IT WITH A DIFFERENT COIL, AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692271 ↗
• MalfunctionMar 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE AT PULMONARY ARTERY, THE COIL (SUBJECT DEVICE) MAY HAVE BECOME ENTANGLED WHEN INSERTING AND REMOVING IT, AND THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED INSIDE THE MICROCATHETER WHEN IT WAS RETRACTED. 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 13884155 ↗
• MalfunctionSep 7, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL PREMATURELY DETACHED/SEPARATED 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 12436933 ↗
• MalfunctionJun 14, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE PERFORMED FOR GASTROINTESTINAL BLEEDING TREATMENT, A COIL (SUBJECT DEVICE) WAS INSERTED INSIDE THE PATIENT¿S ANATOMY IN COMBINATION WITH A MICROCATHETER. THE SUBJECT COIL PREMATURELY DETACHED WITHOUT DETACHMENT ATTEMPT INSIDE THE MICROCATHETER. THE DETACHED SUBJECT COIL WAS REMOVED FROM THE PATIENT'S ANATOMY 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 11995854 ↗
• InjuryMay 3, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT COIL WAS INSERTED INTO THE CATHETER, THE PHYSICIAN TRIED TO REPOSITION IT BY PUTTING IT IN AND OUT MULTIPLE TIMES. DURING THIS REPOSITIONING, THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO COLLECT IT WITH A SNARE, BUT WAS UNSUCCESSFUL. THE PHYSICIAN REMOVED THE SUBJECT COIL FROM THE PATIENT'S ANATOMY IN A SUBSEQUENT SURGICAL PROCEDURE DONE ON THE SAME DAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11767691 ↗
• MalfunctionApr 26, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLIZATION CASE FROM THE CORONARY ARTERY TO THE PULMONARY ARTERY THE MICRO CATHETER WAS GUIDED TO THE OCCLUSION SITE AND THE RESISTANCE WAS FELT WHILE ADVANCING THE SUBJECT COIL OUT OF THE MICRO CATHETER TIP. WHILE THE PHYSICIAN TRIED TO REMOVE THE SUBJECT COIL FROM THE MICRO CATHETER, IT DETACHED PREMATURELY INSIDE THE MICRO CATHETER. SO IT WAS TAKEN OUT OF THE ANATOMY ALONG WITH 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 11729470 ↗
• InjuryNov 4, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE COIL (SUBJECT DEVICE) WAS ATTEMPTED TO INSERT, THERE WAS RESISTANCE WHILE ADVANCING THE COIL INSIDE THE MICROCATHETER. COIL WAS ATTEMPTED TO PULL AND THEN THE COIL DETACHED PREMATURELY (UNINTENTIONALLY WITHOUT USING INZONE). THE COIL WAS REMOVED COMPLETELY USING SNARE. 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 10789120 ↗
• MalfunctionNov 2, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) HAD DIFFICULTY ADVANCING INSIDE THE MICROCATHETER, AND WAS FOUND TO BE PREMATURELY DETACHED INSIDE THE MICROCATHETER DURING THE PROCEDURE. THE COIL WAS PLACED IN THE VESSEL BY PRESSING WITH A DELIVERY WIRE, 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 10774505 ↗
• MalfunctionOct 6, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULDN'T BE DETACHED UPON MULTIPLE DETACHMENT ATTEMPTS DURING THE PROCEDURE. THE SUBJECT COIL GOT PREMATURELY DETACHED INSIDE A MICROCATHETER WHEN THE PHYSICIAN TRIED TO REMOVE THE SUBJECT COIL FROM THE PATIENT'S 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 10635736 ↗
• MalfunctionOct 6, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) COULDN'T BE DETACHED UPON MULTIPLE DETACHMENT ATTEMPTS DURING THE PROCEDURE. THE SUBJECT COIL GOT PREMATURELY DETACHED INSIDE A MICROCATHETER WHEN THE PHYSICIAN TRIED TO REMOVE THE SUBJECT COIL FROM THE PATIENT'S 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 10635735 ↗
• MalfunctionDec 10, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448704 ↗