Target Tetra TG5413580Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327578690), received between Aug 12, 2024 and Aug 12, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Premature Separation; Premature Separation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS PARTIALLY DEPLOYED FROM MICROCATHETER, AND THE SUBJECT MAIN COIL WAS NOTED TO BE DETACHED. 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 22789744 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 24 HOURS POST CRANIAL NEUROVASCULAR PROCEDURE WITH SUBJECT COIL THE PATIENT PRESENTED WITH A NEW DEFICIT (LEFT HEMIPLEGIA). THE PATIENT WAS TAKEN FOR FURTHER STUDIES WHERE CLOT FORMATION WAS NOTICED ON THE SUBJECT COIL THAT HAD BEEN IMPLANTED. THE PATIENT IS CURRENTLY BED - RIDDEN AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis; Thrombosis/Thrombus

  MAUDE report 20526605 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS TO ED (EMERGENCY DEPARTMENT) WITH HEADACHE, NAUSEA AND CONFUSION ON (B)(6) 2024. MAGNETIC RESONANCE IMAGING (MRI) SCAN ON (B)(6) 2024 SHOWS ACUTE MULTIFOCAL PUNCTATE CEREBELLAR STROKE AND ACUTE SAH (SUB ARACHNOID HEMORRHAGE). ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENTS WERE RELATED TO RETREATMENT OF THE ANEURYSM WITH STENT/COIL EMBOLIZATION ON (B)(6) 2024. CANNOT SPECIFY IF IT WAS RELATED SPECIFICALLY TO THE SUBJECT STENT OR COILS. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Confusion/ Disorientation; Embolism/Embolus; Headache; Intracranial Hemorrhage; Ischemia Stroke; Nausea

  MAUDE report 19968071 ↗