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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-2169-2016
Recall Event ID 74425
510(K)Number K113412  K153658  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Target Detachable Coils:
TARGET HELICAL NANO 1.5 MM X 2 CM
MODEL Number:M0035431520


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: M0035431520:  Lot Number/Expiration Date: 18784673 31-Jan-19 18723226 30-Nov-18 18686302 30-Nov-18 18637332 31-Oct-18 18627687 31-Oct-18 18569824 31-Aug-18 18453278 30-Jun-18 18391505 31-May-18 18769932 31-Dec-18 18735994 30-Nov-18 18710356 30-Nov-18 18652851 31-Oct-18 18801847 31-Jan-19 18755945 31-Dec-18 18602481 30-Sep-18 18832966 28-Feb-19 18843005 28-Feb-19 18630099 31-Oct-18 18510994 31-Jul-18 18495363 31-Jul-18 18484141 31-Jul-18 18803162 31-Jan-19 18786297 31-Jan-19 18754879 31-Dec-18 18734778 30-Nov-18 18602423 30-Sep-18 18585290 31-Aug-18 18450430 30-Jun-18 18769816 31-Dec-18 18785485 31-Jan-19 18637274 31-Oct-18 18511110 31-Jul-18 18465901 30-Jun-18 18769700 31-Dec-18 18746995 31-Dec-18 18725103 30-Nov-18 18694228 30-Nov-18 18686012 30-Nov-18 18665561 31-Oct-18 18607752 30-Sep-18 18449575 30-Jun-18 18832355 28-Feb-19 18831744 31-Jan-19 18842138 28-Feb-19 18732878 30-Nov-18 18637216 31-Oct-18 18584252 31-Aug-18 18569882 31-Aug-18 18569766 31-Aug-18 18523410 31-Jul-18 19033487 30-Apr-19 18984845 30-Apr-19 18972140 30-Apr-19 18861952 28-Feb-19 18878607 28-Feb-19 19063170 31-May-19 18923191 31-Mar-19 18897527 28-Feb-19 18897185 28-Feb-19 18910290 31-Mar-19 19032199 30-Apr-19 19002213 30-Apr-19 19002155 30-Apr-19 18950942 31-Mar-19 18897698 28-Feb-19 18858983 28-Feb-19 19031329 30-Apr-19 19031909 30-Apr-19 19002271 30-Apr-19 18951058 31-Mar-19 18950884 31-Mar-19 18896843 28-Feb-19 18897014 28-Feb-19 18879010 28-Feb-19 18909942 31-Mar-19 18910638 31-Mar-19 18843872 28-Feb-19 19031619 30-Apr-19 19002329 30-Apr-19 18878204 28-Feb-19 18886556 28-Feb-19 18938172 31-Mar-19 18939594 31-Mar-19 18951000 31-Mar-19 18897356 28-Feb-19 18885142 28-Feb-19 18971589 30-Apr-19 18950826 31-Mar-19 18860449 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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