Target Tetra TG5412025Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327578577), received between Jul 5, 2023 and Aug 27, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Premature Separation

  It was reported that during coil embolization using a compatible-lumen microcatheter, the resistance was encountered while attempting to retrieve the subject coil. Upon withdrawal, the subject coil stretched and prematurely detached inside the microcatheter shaft. Consequently, the subject coil and microcatheter were retrieved together. The procedure was completed successfully using a replacement coil and microcatheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465998 ↗
• MalfunctionNov 17, 2025Premature Separation; Premature Separation

  THE (COIL) SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE COIL DELIVERY WIRE WAS KINKED AND THE MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577279 ↗
• MalfunctionMar 6, 2025Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT MAIN COIL WAS FOUND TO BE BROKEN/FRACTURED DURING USE. 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 21543245 ↗
• MalfunctionFeb 11, 2025Premature Separation; Premature Separation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. 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 21360927 ↗
• MalfunctionFeb 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE END OF THE DELIVERY WIRE WAS BROKEN DURING THE PROCEDURE. 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 21356498 ↗
• MalfunctionFeb 28, 2024Premature Activation; Premature Activation

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) DETACHED PREMATURELY DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799430 ↗
• MalfunctionDec 22, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE WHEN THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER, THERE WAS RESISTANCE. THE PHYSICIAN ATTEMPTED TO REMOVE IT, BUT THE SUBJECT COIL WAS DETACHED PREMATURELY IN THE CATHETER. THEREFORE, THE SUBJECT COIL WAS REMOVED BY CUTTING OFF THE PROXIMAL PART OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384481 ↗
• InjuryJul 5, 2023Migration; Migration

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR A RUPTURED PCOM (POSTERIOR COMMUNICATING ARTERY) ANEURYSM WHEN DEPLOYED THE SUBJECT COIL, IT CAME OUT OF THE ANEURYSM AND GOT LODGE IN THE DISTAL MCA (MIDDLE CEREBRAL ARTERY) BRANCH. THE PHYSICIAN TRIED TO RETRIEVE THE MIGRATED SUBJECT COIL USING A STENT RETRIEVER BUT WAS UNSUCCESSFUL, INSTEAD THERE WAS HEMORRHAGE WHILE TRYING TO RETRIEVE THE MIGRATED COIL. THIS RESULTED IN EMBOLIZATION OF UNINTENDED VESSEL IN PATIENT, THUS VESSEL HAD TO BE SACRIFICED TO STOP THE BLEED WHILE ALSO LEAVING THE MIGRATED COIL IN THE PATIENT VASCULATURE. PHYSICIAN FEELS THAT THE ANATOMY AND/OR LOCATION OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS A SURGICAL DELAY OF UNKNOWN DURATION DUE TO THE REPORTED ISSUE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism/Embolus; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17263683 ↗