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U.S. Department of Health and Human Services

Class 2 Device Recall Target Detachable Coils

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  Class 2 Device Recall Target Detachable Coils see related information
Date Initiated by Firm June 06, 2016
Date Posted July 11, 2016
Recall Status1 Terminated 3 on March 03, 2017
Recall Number Z-2172-2016
Recall Event ID 74425
510(K)Number K113412  K153658  
Product Classification Device, neurovascular embolization - Product Code HCG
Product 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.
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. 
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Geraldin Ahern
510-413-2593
Manufacturer 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.
FDA Determined
Cause 2		 Process change control
Action Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
Quantity in Commerce 45,302 (8,188 in the U.S.) - total, all model numbers
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HCG and Original Applicant = STRYKER NEUROVASCULAR
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