TARGET M0035469300Recalls & reported problems
Stryker Corporation · 360 Standard 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 04546540676351), received between Oct 30, 2020 and Jan 16, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (2 reports).
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
- Premature Separation2
Patient problems
- Cerebral Edema1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Premature Separation
IT WAS REPORTED THAT THE COIL (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT COIL GOT DETACHED WHEN ATTEMPTED TO DEPLOY INTO THE ANEURYSM. THE PROCEDURE WAS DELAYED BY 15 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24090849 ↗InjuryOct 30, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT SUBARACHNOID HEMORRHAGE, THE COIL (SUBJECT DEVICE) GOT STRETCHED AND DETACHED PREMATURELY AT THE AORTA ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL WITH A SNARE DEVICE, BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER THE PROCEDURE DUE TO BRAIN SWELLING CAUSED BY THROMBOGENIC PROGRESSION AND SPASM DEVELOPED DUE TO THE PREEXISTING SUBARACHNOID HEMORRHAGE.
Patient problems: Cerebral Edema; Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 10767041 ↗
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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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