Target Tetra TG5412045Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327578591), received between Apr 13, 2023 and Feb 18, 2026 — classified as 5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Migration

  DURING BALLOON ASSISTED COIL EMBOLIZATION FOR AN UNRUPTURED ANEURYSM, THE SUBJECT COIL WAS PLACED AND DETACHED AS PLANNED. HOWEVER, AFTER DETACHMENT AND BALLOON DEFLATION, THE ENTIRE COIL MIGRATED INTO THE MIDDLE CEREBRAL ARTERY. A GOOSE NECK SNARE DEVICE WAS USED TO RETRIEVE THE MIGRATED COIL, BUT ARTERIAL BLEEDING WAS OBSERVED. TEMPORARY OCCLUSION WITH THE GUIDING BALLOON WAS APPLIED TO ACHIEVE HEMOSTASIS. ONCE BLEEDING WAS CONTROLLED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT IS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24384439 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  IT WAS REPORTED THE PROXIMAL PART OF THE SUBJECT COIL HAD STRETCHED. THE SUBJECT MAIN COIL HAD PREMATURELY DETACHED DURING USE AND A SNARE WAS USED TO PULL OUT THE SUBJECT MAIN COIL FROM THE ARTERY. 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 23589399 ↗
• InjuryAug 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL PREMATURELY DEPLOYED INSIDE THE MICROCATHETER DURING A BALLOON-ASSISTED COILING PROCEDURE FOR A RUPTURED ANEURYSM. 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 22867680 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT COIL WAS STRETCHED WHILE THE OPERATOR PUSHED IT INTO THE MICROCATHETER. HE EVENTUALLY PULLED OUT THE SUBJECT COIL BEFORE DETACHMENT, USING SNARE AND SUCCESSFULLY REMOVED IT AND KEPT COILING WITH OTHER PRODUCTS. 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 21982291 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE SUBJECT COIL INTO THE MICROCATHETER HUB AND IN THE CATHETER SHAFT. DURING RETRACTION, THE SUBJECT COIL WAS FRACTURED OFF IN THE MICROCATHETER. THEREFORE, THE SUBJECT COIL WAS REPLACED WITH A NEW COIL AS THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977466 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE SUBJECT COIL INTO THE MICROCATHETER HUB AND IN THE CATHETER SHAFT. DURING RETRACTION, THE SUBJECT COIL WAS FRACTURED OFF IN THE MICROCATHETER. THEREFORE, THE SUBJECT COIL WAS REPLACED WITH A NEW COIL AS THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973860 ↗
• MalfunctionNov 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING REPOSITIONING OF THE SUBJECT COILS IN THE ANEURYSM, THE SUBJECT COILS STOPPED MOVING. THE OPERATOR CONCLUDED THAT THE SUBJECT COILS WERE TANGLED AND ATTEMPTED TO RETRIEVE THEM. HOWEVER, THE SUBJECT COILS GOT STRETCHED AND COULD NOT BE RETRACTED. THEY WERE DETACHED BY TORQUE AND REMAINING PART OF THE SUBJECT COILS WAS FLUSHED INTO THE ANEURYSM. 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 20685106 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE ONCE ALL IMPLANTS HAD BEEN DETACHED AND DURING THE CONTROL RUNS WHICH ARE DONE AT THE END OF THE PROCEDURE, CLOT FORMATION WAS NOTED ON THE SUBJECT COIL. THE PATIENT HAD TO BE GIVEN AGGRASTAT INFUSION ON THE TABLE WHICH DELAYED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20517247 ↗
• MalfunctionApr 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL FELT A LITTLE ROUGH DURING TRANSFER, CONTINUED TO ADVANCE THE SUBJECT COIL AND THE PHYSICIAN FELT THAT THE SUBJECT COIL DID NOT TRACK AS WELL AS NORMAL. SUBJECT COIL SUCCESSFULLY DEPOSITED WITHOUT DETACHMENT. UPON DETACHMENT, THE PUSHER WIRE WAS RETRACTED. AS THE MICROCATHETER WAS RETRACTED OUT OF THE ANX, IT WAS NOTED THAT THE SUBJECT COIL WAS STILL CAPTURED WITHIN THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738920 ↗