GDC-10 M003346920SR0Recalls & reported problems
Stryker Corporation · 360 Standard SR Detachable Coil · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540689726), received between Aug 21, 2017 and Aug 21, 2017 — classified as 1 injury.
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
Patient problems
- Hemorrhage, Cerebral1
- Hemorrhage, Subarachnoid1
- Neurological Deficit/Dysfunction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 72 HOURS POST COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM LOCATED ON THE MIDDLE CEREBRAL ARTERY WITH 9 COILS (SUBJECT DEVICES), THE PATIENT SUFFERED ONE SIDE HEMIPLEGIA DUE TO SUBARACHNOID HEMORRHAGE. USE OF DRUGS (RECOMBINANT ACTIVATED FACTORVII, NICARDIPINE) WAS PRESCRIBED IN ORDER TO TREAT THE ADVERSE EVENT. ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENT OF HEMIPLEGIA WAS RELATED TO THE PROCEDURE AND TO ALL OF THE COILS. THIS REPORT CONCERNS THE SIXTH COIL.
Patient problems: Hemorrhage, Cerebral; Hemorrhage, Subarachnoid; Neurological Deficit/Dysfunction
MAUDE report 6809322 ↗
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- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- 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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