Target Tetra TG5411520Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327580099), received between Apr 22, 2024 and Sep 9, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702706 ↗
• MalfunctionJul 16, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841261 ↗
• MalfunctionOct 23, 2025Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL DETACHED PREMATURELY 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 23375704 ↗
• MalfunctionJun 13, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN THE RO MARKER (RADIOPACITY MARKER) ON THE PUSHER WIRE OF THE SUBJECT COIL WAS AT THE APPROPRIATE POINT LINED UP WITH THE PROXIMAL MICROCATHETER MARKER, IT APPEARED EXCESS SUBJECT COIL DELIVERY WIRE WAS OUTSIDE OF THE MICROCATHETER TIP. THE SUBJECT DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL COILS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203923 ↗
• MalfunctionOct 25, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE A MICROCATHETER MIGRATED FROM THE TARGET SITE, THUS THE SUBJECT COIL WAS WITHDRAWN FROM IT. WHEN THE SUBJECT COIL WAS REINSERTED INTO THE MICROCATHETER AND BROUGHT TO THE TARGET LESION IT WAS DISCOVERED THAT THE MAIN COIL WAS MISSING. 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 20535568 ↗
• MalfunctionOct 10, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT SUBJECT COIL DETACHED EARLY WITHOUT USE OF THE DETACHER. THE SUBJECT COIL WAS IMPLANTED SAFELY IN THE PATIENT IN THE END. 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 20421709 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, WHEN THE DETACHMENT MARKER WAS ALIGNED TO DETACH THE SUBJECT COIL, THE COIL TAIL GREATLY EXCEEDED THE MICROCATHETER AND THE DELIVERY WIRE OF THE SUBJECT COIL APPEARED TO BE COMING OUT OF THE MICROCATHETER DISTAL TIP. CONTRAST WAS PERFORMED AND BLEEDING WAS OBSERVED, THEREFORE THE SUBJECT COIL WAS IMMEDIATELY DETACHED, AND ADDITIONAL COILS WERE IMPLANTED AS A MEDICAL INTERVENTION. THE THIRD TO FIFTH COILS COULD BE IMPLANTED WITHOUT ANY ISSUE AND THE BLEEDING STOPPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT'S IMMEDIATE PROGNOSIS WAS NOT SIGNIFICANTLY AFFECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20190388 ↗
• MalfunctionApr 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION CASE, THE SUBJECT COIL WAS RE-SHEATHED TWICE AND WAS SEEN TO BE DETACHED FROM THE SUBJECT COIL DELIVERY WIRE DURING THE PROCEDURE AND COULD NOT BE FOUND. THE PHYSICIAN CONFIRMED THAT THE SUBJECT COIL WAS NOT IN THE BODY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPDATED INFORMATION: THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND WAS EXAMINED, AND IT WAS DISCOVERED THAT THE REPORTED EVENT OF THE SUBJECT COIL BEING PREMATURELY DETACHED/SEPARATED DURING USE WAS NOT CONFIRMED. THE SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE KINKED, MAIN COIL WAS STRETCHED, AND THE SUTURE WAS FOUND DAMAGED UPON RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150944 ↗