Target Tetra TG5412035Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327578584), received between Mar 6, 2024 and Jun 13, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (2 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.
Reports received per month
Most reported problems
Device problems
- Component Misassembled2
- Adverse Event Without Identified Device or Use Problem1
- Device Misassembled During Manufacturing /Shipping1
- Fracture1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT WHEN THE RO MARKER (RADIOPACITY MARKER) ON THE PUSHER WIRE OF THE SUBJECT COIL WAS AT THE APPROPRIATE POINT LINED UP WITH THE PROXIMAL MICROCATHETER MARKER, IT APPEARED EXCESS SUBJECT COIL DELIVERY WIRE WAS OUTSIDE OF THE MICROCATHETER TIP. THE SUBJECT DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL COILS. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203921 ↗MalfunctionMay 8, 2025Device Misassembled During Manufacturing /Shipping; Component Misassembled; Device Misassembled During Manufacturing /Shipping; Component Misassembled
IT WAS REPORTED THE POSITION OF THE RADIOPACITY MARKER ON THE SUBJECT COIL SEEMED MISPLACED. THE SUBJECT COIL SEEMS TO BE MORE AHEAD OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SUBJECT DEVICE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988685 ↗MalfunctionDec 10, 2024Fracture; Fracture
THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DELIVERY WIRE OF THE COIL (SUBJECT DEVICE) WAS FRACTURED DURING USE. 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 20893725 ↗InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE TREATMENT OF A RUPTURED CEREBRAL ANEURYSM, THE SUBJECT COIL WAS IMPLANTED AS THE FIRST COIL. SEVERAL ATTEMPTS WERE MADE TO DETACH IT BUT IT COULD NOT BE DETACHED. DURING RETRIEVAL OF THE SUBJECT COIL, IT GOT STRETCHED AND REMAINED IN THE PATIENT. THE SUBJECT COIL WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. 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 19469061 ↗MalfunctionMar 6, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM PROCEDURE THE SUBJECT COIL DETACHED PREMATURELY WITHIN 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 18843922 ↗
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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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