Target Tetra TG5413560Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327578683), received between Jun 23, 2023 and Feb 10, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration1
- Premature Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Premature Separation
IT WAS REPORTED THAT THE DOUBLE CATHETER TECHNIQUE WAS PERFORMED. ATTEMPTED TO PLACE THE SUBJECT COIL IN THE ANEURYSM; HOWEVER, IT DID NOT ENGAGE WITH THE VESSEL. THEREFORE, THE SUBJECT COIL WAS RETRIEVED AND REINSERTED INTO THE OTHER MICROCATHETER; HOWEVER, IT GOT PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE SUBJECT COIL WAS REMOVED WITH THE ENTIRE 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 24301677 ↗InjuryMay 24, 2024Migration; Migration
IT WAS REPORTED THAT THREE MONTHS POST EMBOLIZATION PROCEDURE, THE SUBJECT COIL MASS MIGRATED, AND PATIENT UNDERWENT RE-TREATMENT DUE TO THE SUBJECT COIL MIGRATION. PATIENT CONDITION FOLLOWING RE-TREATMENT WAS STABLE AND THE RE-TREATMENT WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 19392271 ↗InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE OF ACOM ANEURYSM IN A PATIENT, THE POWER SUPPLY FAILED TO DETACH THE SUBJECT COIL AND DURING THIS TIME THE PHYSICIAN PUSHED THE SUBJECT COIL A LITTLE TOO FAR AND IT SLIGHTLY PERFORATED THE ANEURYSM. IT WAS A TINY PERFORATION. THE PHYSICAIN ENDED UP PUTTING A FEW EXTRA COILS IN AND ALSO USED A BALLOON TO CONTROL BLEEDING AT THE TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: Perforation
MAUDE report 17188387 ↗
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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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