TARGET XL M0036116200Recalls & reported problems
Stryker Corporation · Helical 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327004588), received between Mar 6, 2020 and Jan 25, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Premature Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2022Premature Separation; Premature Separation
THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13344023 ↗MalfunctionMar 6, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE CASE OF A CAROTID BLOWOUT FROM PRIOR RADIATION OF A NECK TUMOR, THE CAROTID WAS SUCCESSFULLY SHUTDOWN WITH A TWO CATHETER TECHNIQUE USING THE MICROCATHETERS AND COILS, AND THE SUBJECT COIL DETACHED PREMATURELY FROM THE MIDDLE SECTION INSIDE THE PATIENT¿S ANATOMY DURING PROCEDURE. THE COIL PUSHER AND A PORTION OF THE COIL WERE SUCCESSFULLY RETRACTED BY THE PHYSICIAN. A PORTION OF THE DETACHED COIL STAYED INSIDE THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 9803277 ↗
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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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