Target Tetra TG5412560Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327578638), received between Apr 18, 2024 and Sep 18, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Premature Separation

  It was reported that the subject coil advanced through the microcatheter into the middle meningeal artery (MMA) but the subject coil would not deploy. However, The subject coil was returned for analysis and the device investigation revealed that the main coil prematurely detached/separated during use. There is no additional information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819212 ↗
• MalfunctionAug 26, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50464492 ↗
• InjuryAug 17, 2026Premature Separation

  It was reported that during procedure, the subject coil got prematurely detached in the microcatheter and the subject coil got retrieved out by using guidewire and it was found to be stretched. 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 50287865 ↗
• MalfunctionNov 6, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PRIOR TO THE EVAR ENDOVASCULAR ANEURYSM REPAIR, WHEN ADVANCING THE SUBJECT COIL WITHIN A MICROCATHETER, RESISTANCE WAS ENCOUNTERED IN THE MIDDLE OF THE SHAFT, AND THE COIL GOT STUCK THERE. WHEN RETRIEVING THE SUBJECT COIL, IT GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE ENTIRE MICROCATHETER WAS REMOVED FROM THE BODY. 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 23493312 ↗
• InjuryMar 17, 2025Migration; Migration

  IT WAS REPORTED THAT 4 MONTHS AFTER SUCCESSFUL SUBJECT COIL IMPLANTATION PROCEDURE FOR A CEREBRAL ANEURYSM, PATENT SUFFERED ACUTE RIGHT LEG WEAKNESS, DIFFICULTY SPEAKING, OBSTRUCTION AND FOUND TO HAVE A STROKE. STROKE WAS CAUSED BY THE SUBJECT COIL THAT HAD MIGRATED OUT OF THE ANEURYSM AND TRAVELLED DISTALLY INTO ANTERIOR CEREBRAL ARTERY. PATIENT UNDERWENT CATHETER ANGIOGRAM, MULTIPLE IMAGING STUDIES AND AN INCREASE ANTI-THROMBOTIC MEDICATION. SHE HAS HAD A STROKE, IS DISABLED FROM LEG WEAKNESS RESULTING FROM COIL MIGRATION.

  Patient problems: Muscle Weakness/Atrophy; Obstruction/Occlusion; Speech Disorder; Stroke/CVA

  MAUDE report 21626709 ↗
• MalfunctionMar 7, 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. THERE WAS A SLIGHT DELAY IN SURGERY DUE TO THE EVENT. 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 21548582 ↗
• InjuryApr 18, 2024Migration; Migration

  IT WAS REPORTED THAT DURING A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM BALLOON ASSISTED COILING PROCEDURE, THE SUBJECT COIL APPEARED TO BE STABLE DURING INITIAL COILING AND ON FINAL ANGIOGRAM FOLLOWING THE TREATMENT. PHYSICIAN PERFORMED A COMPUTED TOMOGRAPHY HOURS AFTER TREATMENT AND SUBJECT COIL TAIL WAS FOUND PROTRUDING FROM THE ANEURYSM INTO THE A1. A SECOND BALLOON ASSISTED COIL PROCEDURE WAS DONE TO SECURE THE ANEURYSM. THE PATIENT IS IN CRITICAL CONDITION DUE TO PULMONARY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140214 ↗