TARGET M0035466150Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676269), received between Jan 17, 2022 and Mar 23, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Premature Separation” (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
- Adverse Event Without Identified Device or Use Problem1
- Premature Separation1
Patient problems
- Cognitive Changes1
- Obstruction/Occlusion1
- Paresis1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING AN ENDOVASCULAR TREATMENT OF GIANT RIGHT INTERNAL CAROTID ARTERY ANEURYSM, WHEN THE SUBJECT COIL WAS WITHDRAWN TO RE-POSITION DUE TO UNSATISFACTORY POSITIONING THE 1ST FEW MILLIMETERS OF THE SUBJECT COIL CAME OUT AND THE SUBJECT COIL SPONTANEOUSLY DETACHED. IT WAS REPORTED THAT THE SUBJECT COIL OCCLUDED THE IMPINGED VESSEL. A STENT WAS DEPLOYED TO REOPEN THE OCCLUDED VESSEL. ANTIPLATELETS WERE ADMINISTERED TO THE PATIENT. IT WAS NOTED THAT THE PROCEDURE TIME WAS PROLONGED BY TWO HOURS AND 48 HOURS POST PROCEDURE PATIENT DEVELOPED FLUCTUATING LEFT SIDED WEAKNESS.
Patient problems: Obstruction/Occlusion; Paresis
MAUDE report 16603679 ↗InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL TRIAL PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT HAD HEMIANOPIA AND DELIRIUM. ON IMAGING, OCCIPITAL MICRO EMBOLIC INFARCTS WERE SEEN WHICH RESULTED IN PROLONGED HOSPITALIZATION FOR THE PATIENT. THE EVENT WAS TREATED WITH PHYSIOTHERAPY AND ORAL OLANZAPIN 5 MG FOR DELIRIUM FOR 5 DAYS AND RECOVERED. IN THE PHYSICIAN'S OPINION, THE EVENT WAS POSSIBLY RELATED TO THE SUBJECT DEVICE AND OTHER STRYKER DEVICES USED IN THE PROCEDURE.
Patient problems: Cognitive Changes; Visual Impairment
MAUDE report 13269566 ↗
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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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