Target Tetra TG5414010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327578737), received between Oct 23, 2024 and Mar 6, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL EXPERIENCED DIFFICULTY CONSTRUCTING THE COIL FRAME. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT IT WAS PREMATURELY DETACHED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537059 ↗
• MalfunctionDec 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHILE PUSHING THE SUBJECT COIL GOT DETACHED WITHIN THE MICROCATHETER. 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 23835176 ↗
• MalfunctionOct 22, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL THROUGH THE CATHETER AND THE COIL GOT PREMATURELY DETACHED/SEPARATED WITHIN THE MICROCATHETER. THE SUBJECT DEVICE 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 23354662 ↗
• MalfunctionMar 12, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE 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 21590051 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE ONCE ALL IMPLANTS HAD BEEN DETACHED AND DURING THE CONTROL RUNS WHICH ARE DONE AT THE END OF THE PROCEDURE, CLOT FORMATION WAS NOTED ON THE SUBJECT COIL. THE PATIENT HAD TO BE GIVEN AGGRASTAT INFUSION ON THE TABLE WHICH DELAYED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20517175 ↗