Target Tetra TG5412060Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327578607), received between May 29, 2024 and Dec 18, 2025 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DEPLOYED IN THE CATHETER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846286 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT COIL GOT STUCK IN THE MICROCATHETER. 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 THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610567 ↗
• MalfunctionJan 31, 2025Fracture; Fracture

  ANALYSIS OF THE SUBJECT COIL REVEALED THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED 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 21287030 ↗
• MalfunctionAug 13, 2024Fracture; 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 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 19975519 ↗
• InjuryMay 29, 2024Migration; Migration

  IT WAS REPORTED THAT DURING VERTEBRAL ANEURYSM PROCEDURE THE OPERATOR USED THE SUBJECT COIL TO DEPLOY INTO THE ANEURYSM. AFTER THE OPERATOR HEARD THREE BEEPS FROM THE DETACHER, HE RETRACTED THE MICROCATHETER AND THE PUSHER WIRE, HOWEVER, THE SUBJECT COIL CAME OUT INTO THE PARENT ARTERY. THE OPERATOR TRIED TO REPASS THE SUBJECT COIL ACROSS WITH THE FLOW DIVERTER TO SECURE THE LOOSE COIL BUT UNSUCCESSFULLY. THE SUBJECT COIL HAD MOVED WITH THE BLOOD FLOW INTO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). THE OPERATOR ATTEMPTED SEVERAL TIMES TO CATCH THE SUBJECT COIL WITH THE STENT RETRIEVER BUT UNSUCCESSFULLY. THE PROCEDURE WAS ABORTED. A SURGICAL DELAY OF 30-45 MINUTES WAS REPORTED DUE TO THIS EVENT. PATIENT WAS PLACED ON ADDITIONAL MEDICATION. PATIENT IS UNDERGOING DIAGNOSTIC ANGIOGRAM POST OP AND THEN TREATMENT OF THE INITIAL ANEURISM THAT IS STILL UNTREATED, WILL HAVE TO BE CONSIDERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19421327 ↗