TARGET M0036182250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327128369), received between Oct 11, 2017 and Sep 29, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHEN THE COIL WAS INSERTED INTO THE MICROCATHETER IT GOT STUCK AT THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL AND THE COIL GOT STRETCHED AND DETACHED PREMATURELY WITHIN THE SHAFT OF MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED ALONG WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23174670 ↗
• MalfunctionFeb 15, 2024Premature Separation; Premature Separation

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS FOUND PREMATURELY DETACHED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712630 ↗
• MalfunctionDec 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN THE COIL (SUBJECT DEVICE) WAS ADVANCED INTO THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE COIL AND IT WAS FOUND BROKEN IN CATHETER. THE COIL WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9490211 ↗
• MalfunctionOct 11, 2017Premature Activation; Premature Activation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6942493 ↗