Target Tetra TG5411530Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327580105), received between Jun 26, 2023 and Sep 23, 2026 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026No Apparent Adverse Event

  It was reported that when physician attempted to insert the subject coil into the microcatheter, the resistance was encountered at the hub. The physician withdrew the delivery wire and introducer sheath for inspection; a thrombus was observed within the introducer sheath. The subject device was replaced, and the procedure was completed successfully.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50867854 ↗
• MalfunctionJul 21, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25895815 ↗
• MalfunctionApr 14, 2026Migration

  IT WAS REPORTED THAT DURING A PROCEDURE FOR M-SEGMENT BIFURCATION OF THE RIGHT MIDDLE CEREBRAL ARTERY, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SUBJECT COIL THROUGH THE MICROCATHETER, THE SUBJECT COIL ENCOUNTERED GREATER RESISTANCE COMPARED TO THE PREVIOUS TWO COILS. MOREOVER, THIS COIL CONSISTENTLY FAILED TO FILL THE ANEURYSM AND KEPT HERNIATING OUT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE SUBJECT COIL MIGRATED OUT OF THE ANEURYSM. 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 24868037 ↗
• MalfunctionFeb 8, 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 24286151 ↗
• MalfunctionJan 26, 2026Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS DETACHED WITHIN THE MICROCATHETER DURING THE PROCEDURE. 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 24180391 ↗
• InjuryNov 18, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ICA-T, PCA, AND SUPRACLINOID ANEURYSM PROCEDURE, THE OPERATOR FIRST TREATED THE ICA-T ANEURYSM WITH A WEB THEN COILED THE L-PCA ANEURYSM. HE DEPLOYED TWO COILS AND THEN ASKED FOR THE SUBJECT COIL. HOWEVER, WHEN HE TRIED TO DETACH THE SUBJECT COIL, IT WOULDN'T DETACH. AFTER THE OPERATOR HEARD THAT THE POWER SUPPLY GAVE THE LONG BEEP HE TRIED TO PULL THE SUBJECT COIL OUT OF THE MICROCATHETER BUT IT REMAINED UNDETACHED. HE REPLACED THE POWER SUPPLY AND TRIED AGAIN, BUT THE SUBJECT COIL STILL WOULD NOT DETACH. WHEN THE OPERATOR TRIED AGAIN THE SUBJECT COIL PARTIALLY DETACHED WITH THE PROXIMAL PORTION IN THE DISTAL END OF THE MICROCATHETER. THE OPERATOR USED A NEW COIL, TO PUSH THE PROXIMAL END OF THE SUBJECT COIL INTO THE ANEURYSM AND THEN FINISHED COILING. 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 23589730 ↗
• MalfunctionSep 3, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE THE BACK OF THE SUBJECT COIL WAS BROKEN WHILE LOADING INTO CATHETER. THE DEVICE WAS REMOVED AND REPLACED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956441 ↗
• InjuryApr 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, AN INCREASE IN EOSINOPHILS AND LOCAL SWELLING WERE DETECTED. AN ALLERGIC REACTION WAS SUSPECTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21870021 ↗
• InjuryMar 12, 2025Migration; Migration

  IT WAS REPORTED THAT DURING 6 MONTHS FOLLOW UP AFTER SUBJECT COIL IMPLANTATION PROCEDURE FOR ANTERIOR CEREBRAL ARTERY ANEURYSM, THE SUBJECT COIL HAD TRAVELLED DISTALLY INTO ANTERIOR CEREBRAL ARTERY. PATIENT CURRENTLY SEEMS ASYMPTOMATIC FROM THIS EVENT. SHE HAS HAD LEG WEAKNESS; HOWEVER, THIS SYMPTOM IS NOT CLEARLY ATTRIBUTABLE TO THIS SUBJECT COIL MIGRATION EVENT. THE PATIENT UNDERWENT ADDITIONAL TESTING BUT DOES NOT APPEAR TO HAVE BEEN INJURED. PATIENT IS CONTINUED ON ANTI-THROMBOTIC MEDICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 21590390 ↗
• MalfunctionNov 25, 2024Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE MAIN COIL 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 20774627 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 24 HOURS POST CRANIAL NEUROVASCULAR PROCEDURE WITH SUBJECT COIL THE PATIENT PRESENTED WITH A NEW DEFICIT (LEFT HEMIPLEGIA). THE PATIENT WAS TAKEN FOR FURTHER STUDIES WHERE CLOT FORMATION WAS NOTICED ON THE SUBJECT COIL THAT HAD BEEN IMPLANTED. THE PATIENT IS CURRENTLY BED - RIDDEN AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis; Thrombosis/Thrombus

  MAUDE report 20524647 ↗
• MalfunctionSep 11, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS INTENDED TO BE PLACED AS THE NINTH COIL. DURING DELIVERY, THE OPERATOR NOTICED A CHANGE IN RESISTANCE WHILE PUSHING THROUGH THE MICROCATHETER (NOT IN THE MASS, BUT THE ENTIRE SUBJECT COIL REMAINED INSIDE THE MICROCATHETER AND WAS VISIBLE UNDER FLUOROSCOPY, WITH NO APPARENT ISSUES). FINDING THIS UNUSUAL, THE OPERATOR RETRACTED THE DELIVERY WIRE UNDER FLUOROSCOPY AND DISCOVERED THAT THE SUBJECT COIL HAD PREMATURELY DETACHED. FORTUNATELY, SINCE THE SUBJECT COIL WAS STILL ENTIRELY INSIDE THE MICROCATHETER, THE MICROCATHETER WAS FULLY WITHDRAWN, AND THE COIL WAS SAFELY RETRIEVED. 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 20189709 ↗
• MalfunctionJun 21, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE UPON INSERTING SUBJECT COIL INTO MICROCATHETER HUB, THERE WAS RESISTANCE. THE OPERATOR PULLED THE COIL BACK AND NOTED THERE WAS NO LONGER A COIL ON THE END OF THE DELIVERY WIRE. THE SUBJECT COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER. 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 19589405 ↗
• InjuryMar 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE ANTERIOR COMMUNICATING ARTERY ANEURYSM PROCEDURE, PHYSICIAN ATTEMPTED TO DETACH THE SUBJECT COIL HOWEVER, POWER SUPPLY SIGNALED THAT THE SUBJECT COIL DID NOT DETACH. PHYSICIAN CHECKED UNDER FLUOROSCOPY AND CONFIRMED THAT THE SUBJECT COIL HAD NOT DETACHED. HOWEVER, THE SUBJECT COIL DETACHED PREMATURELY WITHIN THE PATIENT ANATOMY LATER WHILE ADJUSTING THE MICROCATHETER. THE PHYSICIAN REMOVED THE SUBJECT COIL USING A STENT RETRIEVER. THERE WAS SURGICAL DELAY OF 30 MINUTES NOTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847959 ↗
• 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.

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

  MAUDE report 17690711 ↗
• MalfunctionJul 21, 2023Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT IT WAS BROKEN/FRACTURED DURING USE. 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 17371387 ↗
• InjuryJun 26, 2023Migration; Migration

  IT WAS REPORTED THE COIL (SUBJECT DEVICE) WAS DELIVERED AND DEPLOYED THROUGH A MICROCATHETER INTO THE 1.6MM X 1.7MM PERICOLLOSAL ANEURYSM. AFTER THE MICROCATHETER WAS REMOVED FROM THE ANEURYSM, THE PHYSICIAN DID A CONTRAST RUN AND DISCOVERED THAT THE COIL (SUBJECT DEVICE) HAD DISLODGED OUT OF THE ANEURYSM AND HAD MIGRATED TO ONE OF THE PATIENT¿S TWO A3 BRANCHES. THE PHYSICIAN SPENT SEVERAL HOURS TRYING TO ACCESS THE DISTAL BRANCH WITH THE GOAL OF RETRIEVING THE DISLODGED COIL (SUBJECT DEVICE) BUT WAS UNABLE TO ACCESS THE A3 BRANCH SO THE COIL (SUBJECT DEVICE) COULD NOT BE REMOVED. THE PATIENT WOKE UP APHASIC AND WEAK ON THE RIGHT SIDE. NO ADDITIONAL INFORMATION AVAILABLE. UPDATE: RECEIVED ADDITIONAL INFORMATION ON 29-JUN-2023 STATED THAT MEDICAL INTERVENTION WAS PERFORMED AS THE PHYSICIAN TRIED FOR APPROXIMATELY FOUR HOURS TO RETRIEVE THE SUBJECT COIL BUT THE PHYSICIAN WAS UNABLE TO ACCESS THE VESSEL WHERE THE SUBJECT COIL WAS LODGED. THE PATIENT SUFFERED AN ISCHEMIC STROKE WHICH RESULTED IN PATIENT HOSPITALIZATION. THE PATIENT WAS BEGINNING TO SPEAK AGAIN AND WAS REGAINING SOME MOVEMENT. NO ADDIOTNAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient; Ischemia Stroke; Paresis; Speech Disorder

  MAUDE report 17199812 ↗