Target Tetra TG5413060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327578652), received between Dec 20, 2023 and Apr 21, 2026 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Premature Separation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THE SUBJECT DEVICE WAS REPORTED TO BE REMOVED FROM THE BODY AND REPLACED WITH ANOTHER SIZE. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942520 ↗
• MalfunctionOct 22, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS PUSHED THROUGH THE INTRODUCER SHEATH ALIGNED WITH THE MICROCATHETER HUB AND RESISTANCE WAS ENCOUNTERED AND IT COULD NOT ADVANCE. AFTER SLIGHTLY RETRACTING, THE PHYSICIAN FOUND THAT THE SUBJECT COIL HAD BECOME STRETCHED, AND THE SUBJECT COIL FOUND TO BE PREMATURELY DETACHED INSIDE 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 23357187 ↗
• MalfunctionJan 31, 2025Misassembled; Premature Separation; Misassembled; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS INSERTED INTO THE ANEURYSM AND THE OPERATOR ATTEMPTED TO ALIGN THE MARKERS, THE ENTIRE SUBJECT COIL CAME OUT OF THE MICROCATHETER PREMATURELY. THE SUBJECT COIL WAS RETRIEVED. THE MISALIGNMENT WITH THE MARKER WAS SO LARGE THAT THE MICROCATHETER WAS LEFT IN PLACE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW COIL. THERE WERE NO MISALIGNMENT ISSUES BETWEEN THE MICROCATHETER AND NEW COIL. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284650 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715091 ↗
• MalfunctionJun 21, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A RUPTURED ANEURYSM PROCEDURE, THE SUBJECT COIL COULD NOT BE DETACHED. THE PHYSICIAN REPLACED THE POWER SUPPLY HOWEVER, THE SUBJECT COIL STILL COULD NOT BE DETACHED. PHYSICIAN TRIED TO PULL THE DELIVERY WIRE TO RETRIEVE THE SUBJECT COIL AND THE SUBJECT COIL GOT PREMATURELY DETACHED WITHIN THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN PUSHED THE PREMATURELY DETACHED SUBJECT COIL INTO THE ANEURYSM USING THE COIL DELIVERY WIRE. THE COIL DELIVERY WIRE WAS THEN REMOVED. SINCE, IT WAS A SMALL ANEURYSM, EMBOLIZATION WAS SUCCESSFULLY COMPLETED WITH ONLY ONE COIL. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586657 ↗
• MalfunctionDec 20, 2023Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL (SUBJECT DEVICE) WAS PREMATURELY DETACHED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367010 ↗