Target M0035432560Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676054), received between May 28, 2020 and Jul 1, 2025 — classified as 1 death, 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Migration1
- Premature Separation1
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.
DeathJul 1, 2025Fracture; Premature Separation; Fracture; Premature Separation
IT WAS REPORTED THAT DURING INCIDENTAL CEREBRAL ANEURYSM PROCEDURE, THE OPERATOR TRIED TO EXTRACT THE SUBJECT COIL ONCE THE RELEASE PROCESS HAD STARTED. THE SUBJECT COIL COULD NOT BE REMOVED FROM THE PATIENT'S ANATOMY, WHICH CAUSED PATIENT'S DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375075 ↗MalfunctionMay 28, 2020Migration; Migration
IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION CASE, THE SUBJECT COIL WAS ALREADY PLACED AND SUCCESSFULLY DETACHED INSIDE THE ANEURYSM AND WHEN THE PHYSICIAN TRIED TO REMOVE A DIFFERENT COIL OUTSIDE OF PATIENT'S ANATOMY, THE SUBJECT COIL MIGRATED UNEXPECTEDLY AND CAME OUTSIDE THE PATIENT'S ANATOMY ALONG WITH THE OTHER COIL. THE PHYSICIAN USED NEW COILS TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10099411 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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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