Target M0035433040Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540676061), received between Jul 26, 2016 and Jul 26, 2016 — classified as 1 injury.
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
- Migration or Expulsion of Device1
- Premature Activation1
Patient problems
- Hemorrhage, Cerebral1
- Paralysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2016Break; Migration or Expulsion of Device; Premature Activation; Break; Migration or Expulsion of Device; Premature Activation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE COIL USING AN UNSPECIFIED TYPE OF RETRIEVER. DURING AN ANGIOGRAPHY, A SECOND PART OF THE COIL WAS REPORTED TO BE BROKE INSIDE THE GUIDE CATHETER AND MIGRATED INTO THE PATIENTM2-M3 SEGMENT. THE PHYSICIAN WAS ABLE AGAIN TO RETRIEVE THE SECOND PART OF THE BROKEN COIL USING AN UNSPECIFIED TYPE OF RETRIEVER. AFTER MAGNET RESONANCE CONTROL, THE PATIENT EXPERIENCED BLEEDING ON THE LEFT HEMISPHERE AND AN UNSPECIFIED TYPE OF SURGERY WAS PERFORMED TO DRAIN THE BLEEDING. THE PATIENT IS REPORTED TO HAVE HEMIPARESIS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hemorrhage, Cerebral; Paralysis
MAUDE report 5823346 ↗
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- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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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