GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC ...
FDA Device Recall #Z-1517-2016 — Class II — March 21, 2016
Recall Summary
| Recall Number | Z-1517-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 21, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Neurovascular |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 316 devices, both models |
Product Description
GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable.
Reason for Recall
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Distribution Pattern
Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
Lot / Code Information
Model Number: GDC-18 360 11MM X 30CM; Lot numbers: 17723781, 17735100 and 17818842.
Other Recalls from Stryker Neurovascular
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0021-2025 | Class II | The Trevo Trak 21 Microcatheter is a single-lum... | Aug 30, 2024 |
| Z-1903-2024 | Class II | Trevo ProVue, Catalog: 90184 | Apr 23, 2024 |
| Z-1908-2024 | Class II | DAC 044 115cm, Catalog: 90760 | Apr 23, 2024 |
| Z-1906-2024 | Class II | Trevo Trak 21 Microcatheter, Catalog: 90338 | Apr 23, 2024 |
| Z-1905-2024 | Class II | Trevo NXT ProVue 3 x 32, US, Catalog: 90312 ... | Apr 23, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.