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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-2175-2016
Recall Event ID 74425
510(K)Number K113412  K153658  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Target Detachable Coils:
MODEL Number:M0035443040

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:M0035443040 :  Lot Number/Expiration Date: 18442838 30-Jun-18 18442388 30-Jun-18 18490600 31-Jul-18 18831276 31-Jan-19 18760116 31-Dec-18 18760119 31-Dec-18 18584035 30-Sep-18 18470827 31-Jul-18 18442358 30-Jun-18 18830247 31-Jan-19 18470767 30-Jun-18 18470857 31-Jul-18 18800019 31-Jan-19 18760117 31-Dec-18 18568317 31-Aug-18 18462748 30-Jun-18 18443108 30-Jun-18 18442178 30-Jun-18 18568224 31-Aug-18 18490538 31-Jul-18 18462838 30-Jun-18 18568193 31-Aug-18 18584004 30-Sep-18 18490662 31-Jul-18 18442688 30-Jun-18 19066241 31-May-19 19035290 31-May-19 18902944 28-Feb-19 18877825 28-Feb-19 18973721 30-Apr-19 18846664 31-Jan-19 19081717 31-May-19 19026562 30-Apr-19 18973029 30-Apr-19 18876957 28-Feb-19 18905865 28-Feb-19 19027086 30-Apr-19 19080897 31-May-19 19063669 31-May-19 18845906 31-Jan-19 18845527 31-Jan-19 19026038 30-Apr-19 18902302 28-Feb-19 18846285 31-Jan-19 19081102 31-May-19 18901660 28-Feb-19. 
Recalling Firm/
Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Geraldin Ahern
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