TARGET M0036180820Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327466416), received between Sep 1, 2020 and Feb 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2026Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS BROKEN/FRACTURED 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 24341709 ↗
• MalfunctionApr 30, 2024Expulsion; Premature Separation; Expulsion; Premature Separation

  IT WAS REPORTED THAT DURING STENT ASSISTED COIL EMBOLIZATION CASE, PHYSICIAN TRIED TO RE-SHEATH THE SUBJECT COIL. WHEN IT WAS PULLED BACK TO REMOVE, THE SUBJECT COIL WAS FOUND TO BE STRETCHED AND HAD PREMATURELY DETACHED INSIDE THE PATIENT. IT WAS NOT ATTEMPTED TO REMOVE THE SUBJECT COIL. THERE IS NO IMMEDIATE PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211662 ↗
• MalfunctionJun 19, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT, DURING A NEUROVASCULAR PROCEDURE, THE SUBJECT COIL GOT PREMATURELY DETACHED DURING USE. THE SUBJECT COIL WAS RETRIEVED OUT OF THE PATIENTS BODY ALONG WITH THE MICROCATHETER. 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 17151959 ↗
• MalfunctionMar 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY WITHIN THE 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 16588345 ↗
• MalfunctionFeb 4, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION PROCEDURE, THE RESISTANCE ENCOUNTERED WHEN INSERTING THE SUBJECT COIL INTO THE MICROCATHETER (NON STRYKER) THEN THE SUBJECT COIL WAS PREMATURELY DETACHMENT AFTER INSERTIONS AND REMOVALS TWICE FOR REPOSITIONING. THEREFORE, THE SUBJECT COIL WAS REMOVED WITH THE ENTIRE MICROCATHETER (NON STRYKER) AND REPLACED WITH OTHER COIL TO COMPLETE THE PROCEDURE. 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 16301566 ↗
• MalfunctionMay 10, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT COIL WAS ADVANCED THROUGH THE INTRODUCER SHEATH AND THE SUBJECT COIL GOT STUCK AND DETACHED PREMATURELY DURING DELIVERY INSIDE THE MICROCATHETER IN THE PATIENT'S ANATOMY. THE DETACHED SUBJECT COIL WAS REMOVED FROM THE PATIENT VASCULATURE TOGETHER 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 14349335 ↗
• MalfunctionSep 1, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS INSERTED INTO A MICRO CATHETER AND RESISTANCE WAS ENCOUNTERED AT THE DISTAL PART. THE PHYSICIAN PULLED THE SUBJECT COIL AND IT PREMATURELY DETACHED INSIDE THE MICRO CATHETER. THE SUBJECT COIL AND MICRO CATHETER WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480750 ↗