TARGET M0035423580Recalls & reported problems
Stryker Corporation · 360 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540714756), received between Apr 25, 2017 and Jun 5, 2019 — classified as 1 injury, 1 malfunction.
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
- Premature Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryJun 5, 2019Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT COIL AND THE COIL WAS PREMATURELY DETACHED AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS DELAYED BY 20 MINUTE AND THE RESULT WAS COMPROMISED. CLINICAL CONSEQUENT'S WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8670546 ↗MalfunctionApr 25, 2017Break; Break
DEVICE ANALYSIS OF THE RETURNED DEVICE, REVEALED THAT THE COIL DELIVERY WIRE WAS BROKEN/FRACTURED. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6520810 ↗
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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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