Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: T...
FDA Device Recall #Z-2184-2016 — Class II — June 6, 2016
Recall Summary
| Recall Number | Z-2184-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 6, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Neurovascular |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 45,302 (8,188 in the U.S.) - total, all model numbers |
Product Description
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Reason for Recall
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
Lot / Code Information
MODEL Number:M0035452560; Lot Number/Expiration Date: 18426504 31-May-18 18780350 31-Jan-19 18426444 31-May-18 18532556 31-Aug-18 18794332 31-Jan-19 18830452 31-Jan-19 19036717 31-May-19 19005693 30-Apr-19 19060276 31-May-19 18939358 31-Mar-19 19056621 31-May-19 19037970 31-May-19 18971989 30-Apr-19 18906402 28-Feb-19 18953265 31-Mar-19 18897969 28-Feb-19
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.