Target Tetra TG5412545Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327578621), received between Mar 28, 2023 and Nov 25, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (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.

• InjuryNov 25, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT DURING THE ANTERIOR COMMUNICATING ARTERY PROCEDURE, THE PHYSICIAN TRIED TO DETACH THE SUBJECT COIL. ALTHOUGH THE POWER SUPPLY BEEPED 3 TIMES, THE SUBJECT COIL DID NOT DETACH. THE SUBJECT MAIN COIL STRETCHED AND WAS DISLODGED FROM THE COIL MASS AS THE PHYSICIAN TRIED TO PULL OUT THE SUBJECT COIL DELIVERY WIRE. THE SUBJECT MAIN COIL MIGRATED TO A2 SEGMENT. THE PHYSICIAN THEN DEPLOYED A STENT RETRIEVER AND PULLED THE SUBJECT MAIN COIL INTO THE CATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 20-30 MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649068 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE FOR A 4 MM ANEURYSM WAS ABOUT TO BE TREATED WITHOUT A STENT. A MICROCATHETER WAS GUIDED INTO THE ANEURYSM, AND THE FIRST COIL AND SECOND COIL WERE IMPLANTED. HOWEVER, DURING THE INSERTION OF THE THIRD COIL (SUBJECT DEVICE), IT DID NOT ENGAGE WITH THE MASS, AND WHILE REPOSITIONING IT, IT BECAME ENTANGLED WITH NEAR THE TIP OF THE FIRST COIL IMPLANTED AND MADE A KNOT, MAKING IT IMPOSSIBLE TO RETRIEVE THE THIRD COIL (SUBJECT DEVICE). WHILE PUSHING AND PULLING THE THIRD COIL (SUBJECT DEVICE) TO UNTIE THE KNOT, THE FIRST COIL DEVIATED FROM THE MASS, AND A STENT THAT WAS NOT PLANNED TO USE HAD TO BE USED. BY PUSHING AND PULLING THE COILS, THE KNOT WAS UNTIED, AND THE COIL (SUBJECT DEVICE) WAS MANAGED TO BE RETRIEVED. THREE ADDITIONAL COILS WERE INSERTED INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. HOWEVER, AS A STENT WAS USED, THE PATIENT WILL REQUIRE LONG-TERM MEDICATION. THE EXTENDED OPERATIVE TIME ALSO RESULTED IN INCREASED RADIATION EXPOSURE. THE PATIENT¿S CURRENT CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212717 ↗
• MalfunctionNov 24, 2023Expulsion; Migration; Expulsion; Migration

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION FOR UNRUPTURED ANEURYSM PROCEDURE IN THE BASILAR ARTERY, THE OPERATOR PLACED THE COIL IN THE ANEURYSM AND WITH THE COIL STILL BEING ATTACHED, THE OPERATOR ADVANCED THE STENT TO THE TARGET SITE. AFTER THE STENT WAS DEPLOYED, THE COIL WAS DETACHED. NEXT, THE SUBJECT COIL WAS DELIVERED INTO THE ANEURYSM. WHEN THE OPERATOR HEARD THE NORMAL BEEP SOUND FROM THE POWER SUPPLY WHICH SIGNALED A SUCCESSFUL COIL DETACHMENT, THE DELIVERY WIRE WAS RETRACTED AND THE SUBJECT COIL IN THE ANEURYSM MOVED DURING THE RETRACTION. NEXT, THE THIRD COIL WAS ADVANCED THROUGH THE MICROCATHETER, BUT DUE TO BIG RESISTANCE DURING THE DELIVERY IT WAS RETRACTED TOGETHER WITH THE CATHETER. DURING THE RETRIEVAL THE COILS MOVED TO THE AREA BETWEEN THE ANEURYSM. ANGIOGRAPHY REVEALED THAT A WIRE WAS LEFT IN THE VESSEL BETWEEN THE BASILAR ARTERY AND THE VERTEBRAL ARTERY. SURGICAL DELAY OF 120 MINUTES WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18203650 ↗
• MalfunctionNov 6, 2023Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE, THE PROXIMAL CONTACT OF THE SUBJECT COIL DELIVERY WIRE WAS BENT WHILE INSERTING COIL INTO ANEURYSM AND WOULD NOT DETACH WITH THE POWER SUPPLY. WHEN THE POWER SUPPLY WAS REMOVED FROM THE COIL DELIVERY WIRE , THE DELIVERY WIRE WAS LEFT INSIDE OF THE POWER SUPPLY. THE SUBJECT COIL REMOVED SUCCESSFULLY FROM THE PATIENT AND WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075911 ↗
• MalfunctionMar 28, 2023Migration; Migration

  IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS FULLY IMPLANTED INSIDE THE ANEURYSM. DURING A HAND INJECTION IT WAS NOTICED THAT THE HELICAL PORTION CAME DOWN INTO THE PARENT VESSEL AND THEN RETRACTED BACK INTO THE ANX WITHIN THE SAME RUN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME COIL (SUBJECT DEVICE). NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632330 ↗