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Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurolog...

FDA Device Recall #Z-2166-2016 — Class II — June 6, 2016

Recall Summary

Recall Number Z-2166-2016
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 2 CM MODEL Number:M0035431020 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: M0035431020; Lot Number/Expiration Date: 18785369 31-Jan-19 18741318 30-Nov-18 18719333 30-Nov-18 18583254 30-Sep-18 18557530 31-Aug-18 18429528 30-Jun-18 18818792 31-Jan-19 18801607 31-Jan-19 18772009 31-Dec-18 18771835 31-Dec-18 18758722 31-Dec-18 18748395 31-Dec-18 18740448 30-Nov-18 18709718 30-Nov-18 18725975 30-Nov-18 18726385 30-Nov-18 18544137 31-Aug-18 18517433 31-Jul-18 18447952 30-Jun-18 18818618 31-Jan-19 18818444 31-Jan-19 18740738 30-Nov-18 18544079 31-Aug-18 18510936 31-Jul-18 18824386 31-Jan-19 18784557 31-Jan-19 18772067 31-Dec-18 18741608 31-Dec-18 18686476 30-Nov-18 18568905 31-Aug-18 18517549 31-Jul-18 18824444 28-Feb-19 18824502 31-Jan-19 18818270 31-Jan-19 18758107 31-Dec-18 18726180 30-Nov-18 18686650 30-Nov-18 18664543 31-Oct-18 18647231 31-Oct-18 18647173 31-Oct-18 18568963 31-Aug-18 18458590 30-Jun-18 18391277 31-May-18 18824328 31-Jan-19 18802922 31-Jan-19 18748105 31-Dec-18 18647115 31-Oct-18 18568847 31-Aug-18 18557472 31-Aug-18 18786181 31-Jan-19 18772183 31-Dec-18 18686534 30-Nov-18 18585000 31-Aug-18 18584194 31-Aug-18 18582103 30-Sep-18 18582045 30-Sep-18 18557356 31-Aug-18 18510878 31-Jul-18 18523236 31-Jul-18 18772125 31-Dec-18 18686418 30-Nov-18 18647289 31-Oct-18 18452822 30-Jun-18 18450373 30-Jun-18 19033545 30-Apr-19 19004591 30-Apr-19 19004475 30-Apr-19 19004417 30-Apr-19 18927253 31-Mar-19 18915458 31-Mar-19 18915748 31-Mar-19 18915574 31-Mar-19 18915516 31-Mar-19 18845790 28-Feb-19 19052916 31-May-19 18976256 30-Apr-19 18976844 30-Apr-19 18976550 30-Apr-19 18895388 28-Feb-19 18895098 28-Feb-19 19031967 30-Apr-19 18976403 30-Apr-19 19063228 31-May-19 18941012 31-Mar-19 18957807 31-Mar-19 18896258 28-Feb-19 18865965 28-Feb-19 18885463 28-Feb-19 18845411 28-Feb-19 18984961 30-Apr-19 19032257 30-Apr-19 19031387 30-Apr-19 18928771 31-Mar-19 18928012 31-Mar-19 18846169 31-Jan-19 18866197 28-Feb-19 18846548 28-Feb-19 19052595 31-May-19 18957227 31-Mar-19 18956647 31-Mar-19 18866658 28-Feb-19 18886877 28-Feb-19 19031677 30-Apr-19 19076325 31-May-19 18941476 31-Mar-19 18895678 31-Mar-19 18915690 31-Mar-19 18915632 31-Mar-19 18866890 28-Feb-19 18866429 28-Feb-19 19052274 31-May-19 19065800 31-May-19 19004533 30-Apr-19 19004359 30-Apr-19 18941940 31-Mar-19 19051953 31-May-19 18976697 30-Apr-19 18895968 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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