TARGET M0035479300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540676627), received between Oct 2, 2019 and Oct 4, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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.

• MalfunctionOct 4, 2023Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) HAD DETACHED PREMATURELY 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 17872932 ↗
• MalfunctionMay 9, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, RESISTANCE WAS FELT WHILE ADVANCING THE SUBJECT COIL THROUGH THE CATHETER. WHEN RETRIEVED, IT WAS FOUND THAT THE SUBJECT COIL HAD SEPARATED FROM THE DELIVERY WIRE INSIDE THE MICRO-CATHETER. 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 16900011 ↗
• MalfunctionJan 31, 2022Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT 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 13395415 ↗
• MalfunctionOct 2, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, WHILE PUSHING THE COIL INTO THE MICROCATHETER, THERE WAS A LOT OF FRICTION FELT. THE USER PULLED BACK THE COIL AND FOUND IT DETACHED IN THE HUB OF THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9148921 ↗