TARGET XL M0036107200Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327004762), received between Jul 14, 2020 and Mar 14, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2024Fracture; Fracture
THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE COIL (SUBJECT DEVICE) WAS FRACTURED DURING USE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18908838 ↗InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE COILING OF POSTERIOR CEREBRAL ARTERY WHILE THE SUBJECT COIL WAS BEING REPOSITIONED, THE CATHETER TIP MIGRATED OUT OF THE ANEURYSM MAKING IT UNABLE TO POSITION THE SUBJECT COIL. WHILE ATTEMPTING TO REMOVE THE SUBJECT COIL, IT STRETCHED AND WAS UNABLE TO REMOVE. A SNARE DEVICE WAS USED TO CAPTURE THE SUBJECT COIL AND CATHETER AND THE DEVICES WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS ABORTED AND SCHEDULED FOR A LATER DATE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15691299 ↗MalfunctionJul 14, 2020Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT COIL WAS INSERTED INTO THE MICROCATHETER WHILE DOING SO IT GOT STUCK AND WAS UNABLE TO BE PUSHED OR PULLED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ANALYSIS OF THE DEVICE REVEALED THAT THE MAIN COIL HAD PREMATURELY DEPLOYED; THEREFORE, BASED ON THIS INFORMATION THE EVENT IS DEEMED REPORTABLE AND EMDR WILL BE FILED WITH AN AWARE DATE OF 25-JUN-2020. THE EVENT WILL BE ASSESSED TO REFLECT THE DECISION CHANGE AND EMDR WILL BE FILED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10271277 ↗
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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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