TARGET M0035461030Recalls & reported problems
Stryker Corporation · 360 Standard Detachable Coil · Class 2 · Implant
All models of TARGET (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676139), received between Oct 6, 2016 and Oct 30, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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 16, 2026.
Most reported problems
Device problems
- Premature Activation1
- Premature Separation1
Patient problems
- Cerebral Edema1
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT SUBARACHNOID HEMORRHAGE, THE COIL (SUBJECT DEVICE) GOT STRETCHED AND DETACHED PREMATURELY AT THE AORTA ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL WITH A SNARE DEVICE, BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER THE PROCEDURE DUE TO BRAIN SWELLING CAUSED BY THROMBOGENIC PROGRESSION AND SPASM DEVELOPED DUE TO THE PREEXISTING SUBARACHNOID HEMORRHAGE.
Patient problems: Cerebral Edema; Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 10767045 ↗MalfunctionOct 6, 2016Premature Activation; Premature Activation
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PREMATURELY DETACHED COIL AND THE MICROCATHETER WERE SUCCESSFULLY REMOVED FROM THE PATIENT AS ONE UNIT. THE SAME MICROCATHETER WAS USED AGAIN TO FINISH THE PROCEDURE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6003886 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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