TARGET XL M0036106200Recalls & 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
- 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 07613327004779), received between Nov 27, 2018 and Dec 15, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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.
Most reported problems
Device problems
- Premature Separation2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE PROCEDURE, A MICROCATHETER WAS PLACED AT THE TARGET SITE. UPON INTRODUCTION, THE SUBJECT COIL ENCOUNTERED RESISTANCE. ON WITHDRAWAL, THE SUBJECT COIL BRAID FIBER WAS VISIBLY EXTENDING INTO THE MICROCATHETER. PHYSICIAN REMOVED MICROCATHETER AND SUBJECT COIL TOGETHER. THE DEVICES WERE REPLACED WITH SIMILAR PRODUCTS AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE DEVICE REVEALED THAT THE SUBJECT MAIN COIL WAS PREMATURELY DETACHED/SEPARATED DURING USE. THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND EMDR WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11009346 ↗InjuryNov 27, 2018Unintended Movement; Premature Separation; Unintended Movement; Premature Separation
DURING THE COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE SECOND COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER WHEN THE PHYSICIAN TRIED TO REPOSITION THE COIL BY RE-SHEATHING IT INTO THE MICROCATHETER. AND PART OF THE MAIN COIL WAS PROTRUDED OUT OF THE ANEURYSM. THEREFORE, OTHER COILS WERE IMPLANTED TO PUSH THE COIL INSIDE AND PLAVIX WAS ADMINISTRATED TO THE PATIENT. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8108554 ↗
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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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