TARGET M0035471130Recalls & reported problems
Stryker Corporation · 360 Soft 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 07613252192664), received between Sep 3, 2021 and Aug 7, 2023 — classified as 2 malfunctions.
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.
Most reported problems
Device problems
- Fracture1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, WHILE TRYING TO DEPLOY THE SUBJECT COIL, IT GOT PREMATURELY DEPLOYED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17477264 ↗MalfunctionSep 3, 2021Fracture; Fracture
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT COIL DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12425147 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 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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