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Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Tar...

FDA Device Recall #Z-2172-2016 — Class II — June 6, 2016

Recall Summary

Recall Number Z-2172-2016
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 3CM MODEL Number:M0035442030 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: M0035442030: Lot Number/Expiration Date: 18824618 31-Jan-19 18789433 31-Jan-19 18789313 31-Jan-19 18567759 31-Aug-18 18809910 31-Jan-19 18758958 31-Dec-18 18727834 30-Nov-18 18643654 31-Oct-18 18583601 31-Aug-18 18516768 31-Jul-18 18440858 30-Jun-18 18824978 31-Jan-19 18770574 31-Dec-18 18679027 30-Nov-18 18654466 31-Oct-18 18554671 31-Aug-18 18727594 30-Nov-18 18702335 30-Nov-18 18679058 30-Nov-18 18554733 31-Aug-18 18583632 30-Sep-18 18824858 31-Jan-19 18816099 31-Jan-19 18789193 31-Jan-19 18770164 31-Dec-18 18721125 30-Nov-18 18667475 31-Oct-18 18470167 31-Jul-18 18440828 30-Jun-18 18770369 31-Dec-18 18758838 31-Dec-18 18740007 31-Dec-18 18654404 31-Oct-18 18515390 31-Jul-18 18824738 31-Jan-19 18789553 31-Jan-19 18727714 30-Nov-18 18567790 31-Aug-18 18489524 31-Jul-18 18462508 30-Jun-18 18434346 30-Jun-18 18810270 31-Jan-19 18810150 31-Jan-19 18810030 31-Jan-19 18816010 31-Jan-19 18740154 31-Dec-18 18715530 30-Nov-18 18702304 30-Nov-18 18654497 31-Oct-18 18437093 30-Jun-18 18437033 30-Jun-18 18992597 30-Apr-19 19071307 31-May-19 18946838 31-Mar-19 18897907 28-Feb-19 18869664 28-Feb-19 18847712 31-Jan-19 18992628 30-Apr-19 19045040 31-May-19 19044951 31-May-19 19071071 31-May-19 19014571 30-Apr-19 18933425 31-Mar-19 18933692 31-Mar-19 18947016 31-Mar-19 18897814 28-Feb-19 18869810 28-Feb-19 18881694 28-Feb-19 19054629 31-May-19 19054753 31-May-19 19014726 30-Apr-19 18869869 31-Mar-19 18881787 28-Feb-19 18848068 31-Jan-19 19044862 31-May-19 19014602 30-Apr-19 18976136 30-Apr-19 18961238 31-Mar-19 18911301 28-Feb-19 18933603 31-Mar-19 19045129 31-May-19 19014664 30-Apr-19 18961118 31-Mar-19 18947105 31-Mar-19 18946927 31-Mar-19 18897876 28-Feb-19 18869748 28-Feb-19 18881725 28-Feb-19 18992659 30-Apr-19 19054691 31-May-19 19030837 30-Apr-19 19054815 31-May-19 19065247 31-May-19 19071543 31-May-19 19014633 30-Apr-19 18976225 30-Apr-19 18976047 30-Apr-19 18911332 28-Feb-19 18869954 28-Feb-19 18881663 28-Feb-19 18881756 28-Feb-19 19054877 31-May-19 19030570 30-Apr-19 19030481 30-Apr-19 19014695 30-Apr-19 18975958 30-Apr-19 18897938 28-Feb-19 18950354 31-Mar-19 18946749 31-Mar-19 18897845 28-Feb-19 19030926 30-Apr-19 18992690 30-Apr-19 19030659 30-Apr-19 19045218 31-May-19 18933514 31-Mar-19 18950416 31-Mar-19 18933336 31-Mar-19 18911270 28-Feb-19 18848246 28-Feb-19 18847890 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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