Target M0035432540Recalls & reported problems
Stryker Corporation · Helical Ultra 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676047), received between Jan 31, 2018 and Nov 25, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
Patient problems
- 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.
MalfunctionNov 25, 2020Fracture; Fracture
ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL BROKEN/FRACTURED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10902421 ↗MalfunctionJan 31, 2018Break; Break
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE COIL WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED DUE TO THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7232915 ↗
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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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