TARGET M0035423040Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540675873), received between Feb 14, 2017 and Oct 21, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT COIL GOT BROKE OFF WITHIN THE MICROCATHETER. THE SURGERY WAS DELAYED BY 10 MINUTES. THE SUBJECT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354568 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) 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 18984342 ↗
• MalfunctionSep 20, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE HE SUBJECT COIL GOT STUCK IN THE PROXIMAL OF THE MICROCATHETER. THE SUBJECT COIL COULD NOT BE ADVANCED NOR RETRACTED AND GOT PREMATURELY DETACHED INSIDE OF THE MICROCATHETER. THUS, BOTH DEVICES WERE REPLACED WITH THE NEW ONES, 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 17786563 ↗
• MalfunctionFeb 14, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ENDOVASCULAR EMBOLIZATION PROCEDURE IN A PATIENT, THERE WAS STRONG RESISTANCE WHEN THE SUBJECT COIL WAS USED WITH THE MICROCATHETER SO AN ATTEMPT WAS MADE TO REMOVE THE SUBJECT COIL, BUT IT GOT STUCK WITHIN THE MICROCATHETER. EXCESSIVE FORCE WAS APPLIED TO RETRIEVE THE COIL, BUT THERE WAS A FEELING OF PREMATURELY DETACHING THE SUBJECT COIL IN THE MICROCATHETER. THUS, THE ENTIRE MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING BOTH THE DEVICES. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375422 ↗
• MalfunctionNov 11, 2022Premature Separation; Premature Separation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS FOUND TO BE PREMATURELY DETACHED/SEPARATED DURING USE. 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 15784440 ↗
• MalfunctionOct 16, 2020Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT COIL WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10688280 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE COIL (SUBJECT DEVICE) STRETCHED AND A RETRIEVER WAS USED TO REMOVE THE COIL. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118453 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) RUPTURED THE ANEURYSM, RESULTING IN SURGICAL DELAY AND SUBARACHNOID HEMORRHAGE. THE PHYSICIAN CONTINUED TO COIL TO STOP THE BLEED AND REPORTED THE PATIENT'S ANATOMY WAS TORTUOUS.

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 7894799 ↗
• MalfunctionFeb 14, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE COIL RADIO OPAQUE MARKER (SUBJECT DEVICE) AND THE SECOND MARKER OF THE MICROCATHETER WERE ALIGNED, THE MAIN COIL WAS COMPLETELY OUT OF THE MICROCATHETER'S TIP. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330986 ↗