Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology:...
FDA Device Recall #Z-2165-2016 — Class II — June 6, 2016
Recall Summary
| Recall Number | Z-2165-2016 |
| 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 1 MM X 1 CM MODEL Number:M0035431010 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: M0035431010 Lot Number/Expiration Date: 18784731 31-Jan-19 18767279 31-Dec-18 18685490 30-Nov-18 18592036 30-Sep-18 18818328 31-Jan-19 18723284 30-Nov-18 18630215 31-Oct-18 18601959 30-Sep-18 18414374 31-May-18 18748453 31-Dec-18 18730570 30-Nov-18 18606940 30-Sep-18 18403443 31-May-18 18818502 31-Jan-19 18796245 31-Jan-19 18627513 31-Oct-18 18601901 30-Sep-18 18581353 30-Sep-18 18484777 31-Jul-18 18818676 31-Jan-19 18777759 31-Dec-18 18484661 31-Jul-18 18429414 30-Jun-18 18801963 31-Jan-19 18803278 31-Jan-19 18786355 31-Jan-19 18776711 31-Dec-18 18767778 31-Dec-18 18723052 30-Nov-18 18539797 31-Aug-18 18417674 31-May-18 18831860 31-Jan-19 18818850 31-Jan-19 18739085 30-Nov-18 18833082 31-Jan-19 18748163 31-Dec-18 18738163 30-Nov-18 18602017 30-Sep-18 18581469 31-Aug-18 18543905 31-Aug-18 18450658 30-Jun-18 19002735 30-Apr-19 18941882 31-Mar-19 18941418 31-Mar-19 18930269 31-Mar-19 18894264 28-Feb-19 18893885 28-Feb-19 18885637 28-Feb-19 18957343 31-Mar-19 18956763 31-Mar-19 18940954 31-Mar-19 18857373 28-Feb-19 18975521 30-Apr-19 18975084 30-Apr-19 18847507 28-Feb-19 18930614 31-Mar-19 18847275 31-Jan-19 19002909 30-Apr-19 18929924 31-Mar-19 18847333 31-Jan-19 19062880 31-May-19 19002851 30-Apr-19 19002677 30-Apr-19 18974210 30-Apr-19 18930959 31-Mar-19 18906932 31-Mar-19 19046992 31-May-19 19002793 30-Apr-19 18893506 28-Feb-19 18887051 28-Feb-19 18847391 28-Feb-19 18984787 30-Apr-19 19037618 31-May-19 19064752 31-May-19 18894643 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.