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Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Ta...

FDA Device Recall #Z-2160-2016 — Class II — June 6, 2016

Recall Summary

Recall Number Z-2160-2016
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 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 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: M0035421020: Lot Number/Expiration Date: 18825272 31-Jan-19 18811666 31-Jan-19 18819711 31-Jan-19 18790659 31-Jan-19 18701550 30-Nov-18 18628881 31-Oct-18 18598937 30-Sep-18 18562915 31-Aug-18 18582507 30-Sep-18 18582275 31-Aug-18 18819885 31-Jan-19 18811840 31-Jan-19 18742370 30-Nov-18 18714594 30-Nov-18 18723922 30-Nov-18 18701782 30-Nov-18 18701608 30-Nov-18 18677925 30-Nov-18 18657200 31-Oct-18 18667185 31-Oct-18 18667069 31-Oct-18 18647521 31-Oct-18 18599227 30-Sep-18 18582565 30-Sep-18 18553961 31-Aug-18 18790775 31-Jan-19 18790543 31-Jan-19 18742602 31-Dec-18 18647347 31-Oct-18 18604218 30-Sep-18 18585521 31-Aug-18 18515100 31-Jul-18 18825330 31-Jan-19 18790717 31-Jan-19 18723864 30-Nov-18 18742428 31-Dec-18 18714478 30-Nov-18 18729520 30-Nov-18 18677693 30-Nov-18 18657142 31-Oct-18 18638318 31-Oct-18 18647405 31-Oct-18 18604160 30-Sep-18 18825156 31-Jan-19 18825214 31-Jan-19 18819827 31-Jan-19 18811724 31-Jan-19 18729346 30-Nov-18 18701724 30-Nov-18 18657316 31-Oct-18 18623511 30-Nov-18 18647463 31-Oct-18 18599053 30-Sep-18 18591050 30-Sep-18 18534835 31-Aug-18 18819769 31-Jan-19 18811608 31-Jan-19 18825098 31-Jan-19 18759488 31-Dec-18 18701434 30-Nov-18 18667011 31-Oct-18 18628939 31-Oct-18 18598879 30-Sep-18 18591108 30-Sep-18 18562741 31-Aug-18 18534777 31-Aug-18 18790485 31-Jan-19 18701492 30-Nov-18 18666953 31-Oct-18 18638260 31-Oct-18 18598995 30-Sep-18 18599111 30-Sep-18 18554135 31-Aug-18 18515042 31-Jul-18 18469498 31-Jul-18 18447937 30-Jun-18 18811550 31-Jan-19 18790601 31-Jan-19 18677809 30-Nov-18 18591166 30-Sep-18 18590992 30-Sep-18 18582449 30-Sep-18 18582391 31-Aug-18 18582333 31-Aug-18 18554019 31-Aug-18 18515274 31-Jul-18 18488746 31-Jul-18 18965760 31-Mar-19 19030868 30-Apr-19 19030690 30-Apr-19 19044166 31-May-19 18977312 30-Apr-19 19071102 31-May-19 19013933 30-Apr-19 19071338 31-May-19 18977223 30-Apr-19 18946958 31-Mar-19 18896552 28-Feb-19 18916270 31-Mar-19 19082881 31-May-19 19030512 31-May-19 19030601 30-Apr-19 19030423 30-Apr-19 19070866 31-May-19 19014107 30-Apr-19 18896730 28-Feb-19 18916212 31-Mar-19 18871405 28-Feb-19 19044108 31-May-19 18998870 30-Apr-19 18916328 31-Mar-19 18896641 28-Feb-19 18847217 28-Feb-19 19082823 31-May-19 18998696 30-Apr-19 18998754 30-Apr-19 18956299 31-Mar-19 18946869 31-Mar-19 18887631 28-Feb-19 18916444 31-Mar-19 19054107 31-May-19 19043992 31-May-19 19013875 30-Apr-19 18947047 31-Mar-19 18965876 30-Apr-19 18977579 30-Apr-19 18946780 31-Mar-19 18871639 28-Feb-19 19013991 30-Apr-19 18965992 31-Mar-19 18977490 30-Apr-19 18946691 31-Mar-19 18871880 28-Feb-19 19053759 31-May-19 19053585 31-May-19 19030779 30-Apr-19 19014049 30-Apr-19 18998812 30-Apr-19 19065042 31-May-19 18965644 31-Mar-19 18931829 31-Mar-19 18931597 31-Mar-19 18878088 28-Feb-19 18846985 28-Feb-19 19053933 31-May-19 19044050 31-May-19 18956241 31-Mar-19 18887747 28-Feb-19 18931365 31-Mar-19 18878146 28-Feb-19 18916386 31-Mar-19 18916502 31-Mar-19 18872114 28-Feb-19.

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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.

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