Target Tetra TG5412535Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327578614), received between Sep 6, 2023 and May 6, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL DELIVERY WIRE WAS 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 25097462 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE OF UNRUPTURED ANEURYSM, THE OPERATOR USED A DOUBLE CATHETER TECHNIQUE. THE SUBJECT COIL WAS INSERTED INTO THE ANEURYSM FROM ONE CATHETER, AND WITHOUT DETACHING IT, ANOTHER COIL WAS INSERTED FROM THE SECOND CATHETER. NEXT, THE OPERATOR TRIED TO DETACH THE SUBJECT COIL, HOWEVER, IT COULD NOT BE DETACHED. WHEN THE OPERATOR ATTEMPTED TO RETRIEVE THE SUBJECT COIL, A RUPTURE OF THE ANEURYSM OCCURRED. ADDITIONAL INSERTION OF COILS FROM THE SECOND CATHETER STOPPED THE BLEEDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, THERE IS A POSSIBILITY OF SOME SEQUELAE DUE TO INTRAOPERATIVE RUPTURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 22612650 ↗
• MalfunctionJul 8, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS USED FOR COILING AN ANEURYSM OFF THE BASILAR ARTERY AND SCA. AFTER DEPLOYING ABOUT 75% OF THE SUBJECT COIL, IT WOULDN'T STAY IN THE ANEURYSM AFTER A FEW ATTEMPTS AND THUS, THE SUBJECT COIL ALONG WITH THE MICROCATHETER WAS WITHDRAWN AND THE RESISTANCE WAS ENCOUNTERED, ULTIMATELY NOT ALLOWING THE SUBJECT COIL TO BE PULLED BACK INTO THE MICROCATHETER. THE SUBJECT COIL WAS PARTIALLY DEPLOYED THROUGH THE GUIDE CATHETER. THE SUBJECT COIL WAS REPLACED WITH A SMALLER SIZE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. UPON EXAMINATION OUTSIDE OF THE PATIENT; THE SUBJECT COIL HAD FORMED A KNOT ON ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439301 ↗
• InjurySep 6, 2023Migration; Migration

  IT WAS REPORTED POST THE PCOM ANEURYSM PROCEDURE, THE SUBJECT COIL MASS DISLODGED FROM THE TREATMENT SITE RESULTING IN ANEURYSM RE-RUPTURE. THE COIL MASS WAS NOT ATTEMPTED TO BE REMOVED AND REMAINS IN THE PATIENTS M1. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON THE 28 SEP 2023 FROM THE COMPLAINT INTAKE CENTER CLARIFIED THAT THE TREATMENT OCCURRED BECAUSE OF THE ANEURYSM RE-RUPTURE AND IT WAS MONTHS AFTER INITIAL COIL TREATMENT THAT THE ANEURYSM RE-RUPTURE OCCURRED. THE COIL MIGRATION OCCURRED HOURS AFTER THE TREATMENT FOR THE ANEURYSM RE-RUPTURE. THEREFORE THE COIL MASS DISLODGING FROM THE TREATMENT SITE DID NOT RESULT IN ANEURYSM RE-RUPTURE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Ruptured Aneurysm

  MAUDE report 17690601 ↗