Target Tetra TG5413080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327578669), received between Jan 23, 2024 and Feb 9, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL DETACHED IN THE MICROCATHETER. 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 24292025 ↗
• MalfunctionNov 6, 2025Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT COIL SEEN TO BE BROKEN/FRACTURED. 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 23491626 ↗
• MalfunctionApr 4, 2025Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND WAS EXAMINED. DURING DEVICE INVESTIGATION AND ANALYSIS, IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) WAS FRACTURED. 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 21778839 ↗
• InjuryMar 11, 2025Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT DURING RIGHT POSTERIOR COMMUNICATING ARTERY (PCOMA) ANEURYSM PROCEDURE, THE OPERATOR PERFORMED STENT ASSISTED COILING. THE SUBJECT COIL FAILED TO DETACH EVEN WITH NEW POWER SUPPLY. WHEN THE SUBJECT COIL AND MICROCATHETER WERE PULLED, THEY GOT STRETCHED. THE SUBJECT COIL SUDDENLY BROKE OUT AND THE LOOP OF THE SUBJECT COIL MIGRATED TO THE PARENT ARTERY. THE OPERATOR USED STENT TO ATTACH THE SUBJECT COIL LOOP TO THE VESSEL WALL. THE OPERATOR TRIED TO SELECT THE CATHETER TO ANEURYSM TO PUT THE SUBJECT COIL AGAIN, BUT SELECTION WAS IMPOSSIBLE SINCE THE STENT WAS BIFOLD. THEREFORE, THE PROCEDURE COMPLETED WITH JUST ATTACHING THE SUBJECT COIL ON THE VESSEL WALL. THERE WAS A SURGICAL DELAY OF 15 MIN DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21580424 ↗
• MalfunctionFeb 12, 2025Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL DELIVERY WIRE 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 21367554 ↗
• MalfunctionDec 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT COIL ENCOUNTERED RESISTANCE WHILE BEING ADVANCING WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS FOUND TO BE BROKEN/FRACTURED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887783 ↗
• MalfunctionSep 24, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE SUBJECT COIL DELIVERY WIRE HAD BROKEN DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292862 ↗
• InjuryMay 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER THE SUBJECT COIL WAS DETACHED AND THE DELIVERY WIRE WAS REMOVED, THE OPERATOR NOTICED THAT THE SMALL PART OF THE SUBJECT COIL REMAINED IN THE DETACHMENT JUNCTION AREA. THE OPERATOR REMOVED THE SMALL PART OF THE SUBJECT COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19294400 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE COIL (SUBJECT DEVICE) WAS PARTIALLY DEPLOYED, IT WAS STRETCHED WHEN TRYING TO RESHEATH IT BACK TO MICROCATHETER FROM THE ANEURYSM SAC. THE STRETCHED COIL (SUBJECT DEVICE) WAS PUSHED TOWARDS ECA AND A STENT WAS DEPLOYED ACROSS ANEURYSM NECK AS A MEDICAL INTERVENTION TO ENSURE ITS PATENCY. IT WAS STRESSFUL SITUATION AND PATIENT NEEDING TO TAKE ANTIPLATELETS FOR THE STENT AND COIL LOOP. PATIENT WAS UNDER GA (GENERAL ANESTHESIA). THERE WAS A SURGICAL DELAY OF ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES REPORTED TO THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565484 ↗