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Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Tar...

FDA Device Recall #Z-2173-2016 — Class II — June 6, 2016

Recall Summary

Recall Number Z-2173-2016
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 2MM X 4CM MODEL Number:M0035442040 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: M0035442040: Lot Number/Expiration Date: 18824889 31-Jan-19 18789584 31-Jan-19 18715147 30-Nov-18 18654621 31-Oct-18 18583663 31-Aug-18 18779217 31-Dec-18 18771773 31-Dec-18 18758989 31-Dec-18 18715561 30-Nov-18 18567945 31-Aug-18 18583694 30-Sep-18 18489927 31-Jul-18 18456251 30-Jun-18 18456101 30-Jun-18 18779279 31-Dec-18 18789344 31-Jan-19 18771711 31-Dec-18 18715383 30-Nov-18 18679151 30-Nov-18 18568131 31-Aug-18 18470407 30-Jun-18 18818239 31-Jan-19 18810301 31-Jan-19 18721156 30-Nov-18 18702459 30-Nov-18 18521395 31-Jul-18 18824769 31-Jan-19 18779248 31-Dec-18 18702490 30-Nov-18 18654590 31-Oct-18 18436562 30-Jun-18 18825009 31-Jan-19 18818208 31-Jan-19 18810061 31-Jan-19 18702552 30-Nov-18 18741929 30-Nov-18 18667537 31-Oct-18 18567883 31-Aug-18 18456191 30-Jun-18 18440768 30-Jun-18 18824649 31-Jan-19 18810181 31-Jan-19 18809941 31-Jan-19 18758869 31-Dec-18 18741991 30-Nov-18 18741898 30-Nov-18 18568007 31-Aug-18 18470287 30-Jun-18 18440708 30-Jun-18 18393710 31-May-18 18818177 31-Jan-19 18789464 31-Jan-19 18759109 31-Dec-18 18727865 30-Nov-18 18727745 30-Nov-18 18727625 30-Nov-18 18679089 30-Nov-18 18679120 30-Nov-18 18654528 31-Oct-18 18643778 31-Oct-18 18567914 31-Aug-18 18583725 30-Sep-18 18489834 31-Jul-18 19029955 30-Apr-19 19054722 31-May-19 19029924 30-Apr-19 19045373 31-May-19 19045249 31-May-19 19014943 30-Apr-19 18881427 28-Feb-19 18881017 28-Feb-19 18990009 30-Apr-19 19014850 30-Apr-19 18950447 31-Mar-19 18881632 28-Feb-19 18932694 31-Mar-19 18946218 31-Mar-19 19054784 31-May-19 19045404 31-May-19 19065216 31-May-19 18977548 30-Apr-19 18977459 30-Apr-19 18977370 30-Apr-19 18932725 31-Mar-19 19054660 31-May-19 19014757 30-Apr-19 18896432 28-Feb-19 18847681 31-Jan-19 19071276 31-May-19 19071040 31-May-19 19071512 31-May-19 19014881 30-Apr-19 19014819 30-Apr-19 18961269 31-Mar-19 18950385 31-Mar-19 19045342 31-May-19 18932663 31-Mar-19 18932632 31-Mar-19 18896699 28-Feb-19 18896610 28-Feb-19 18864702 28-Feb-19 18881222 28-Feb-19 18848037 28-Feb-19 19054846 31-May-19 19029893 30-Apr-19 19014788 30-Apr-19 18950323 31-Mar-19 18896521 28-Feb-19 18915222 28-Feb-19 18864775 28-Feb-19 18847859 31-Jan-19 19054908 31-May-19 19045311 31-May-19 18977637 30-Apr-19 19014974 30-Apr-19 18946365 31-Mar-19 18915017 28-Feb-19 18914812 28-Feb-19 18864836 28-Feb-19 18848215 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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