Target Tetra TG5413045Recalls & reported problems
Stryker Corporation · Detachable Coil · Class 2 · Implant
All models of Target Tetra (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327578645), received between Jul 10, 2023 and Dec 2, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Fracture1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Fracture; Fracture
THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE BROKEN/FRACTURED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700805 ↗InjurySep 17, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE PROCEDURE; THE SUBJECT COIL BECAME STUCK INSIDE THE CATHETER AND WOULD NOT ADVANCE FORWARD OR BACKWARD NOR DETACH WITH INZONE. EVENTUALLY THE COIL CAME OFF OF THE DELIVERY WIRE AND LEFT LOOP IN PARENT VESSEL. THE PHYSICIAN HAD TO PLACE A NEUROFORM ATLAS STENT TO TACK DOWN LOOP. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075262 ↗MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS MOLD INSIDE THE PACKAGE LID OF THE SUBJECT DEVICE. IT WAS NOT NOTICED UNTIL AFTER THE SUBJECT DEVICE WAS IMPLANTED IN THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17295425 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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