GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intr...

FDA Device Recall #Z-0480-2015 — Class II — October 22, 2014

Recall Summary

Recall Number Z-0480-2015
Classification Class II — Moderate risk
Date Initiated October 22, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Neurovascular
Location Fremont, CA
Product Type Devices
Quantity 1 unit

Product Description

GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's 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

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Distribution Pattern

US Distribution to the states of: VA, NH, OH and TX.

Lot / Code Information

Model M00334820330, Lot number: 12881100; Exp. Jul 2012.

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.