TARGET XL M0036102250Recalls & reported problems
Stryker Corporation · 360 Standard Detachable Coil · Class 2 · Implant
All models of TARGET XL (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327004748), received between Nov 23, 2019 and Nov 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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.
Most reported problems
Device problems
- Premature Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2019Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING PROCEDURE, WHILE DEPLOYING A SECOND STENT (SUBJECT DEVICE), THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER (NON-STRYKER DEVICE). THE MAIN COIL WAS OUTSIDE THE CATHETER AND THE REMAINING PART WAS ENTIRELY INSIDE THE MICROCATHETER. THE DETACHED COIL WAS COMPLETELY REMOVED FROM THE PATIENT¿S BODY BY WITHDRAWAL OF CATHETER WITH THE COIL INSIDE THE MICROCATHETER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9367077 ↗
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- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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