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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-2166-2016
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 MM X 2 CM
MODEL Number:M0035431020


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: M0035431020;  Lot Number/Expiration Date: 18785369 31-Jan-19 18741318 30-Nov-18 18719333 30-Nov-18 18583254 30-Sep-18 18557530 31-Aug-18 18429528 30-Jun-18 18818792 31-Jan-19 18801607 31-Jan-19 18772009 31-Dec-18 18771835 31-Dec-18 18758722 31-Dec-18 18748395 31-Dec-18 18740448 30-Nov-18 18709718 30-Nov-18 18725975 30-Nov-18 18726385 30-Nov-18 18544137 31-Aug-18 18517433 31-Jul-18 18447952 30-Jun-18 18818618 31-Jan-19 18818444 31-Jan-19 18740738 30-Nov-18 18544079 31-Aug-18 18510936 31-Jul-18 18824386 31-Jan-19 18784557 31-Jan-19 18772067 31-Dec-18 18741608 31-Dec-18 18686476 30-Nov-18 18568905 31-Aug-18 18517549 31-Jul-18 18824444 28-Feb-19 18824502 31-Jan-19 18818270 31-Jan-19 18758107 31-Dec-18 18726180 30-Nov-18 18686650 30-Nov-18 18664543 31-Oct-18 18647231 31-Oct-18 18647173 31-Oct-18 18568963 31-Aug-18 18458590 30-Jun-18 18391277 31-May-18 18824328 31-Jan-19 18802922 31-Jan-19 18748105 31-Dec-18 18647115 31-Oct-18 18568847 31-Aug-18 18557472 31-Aug-18 18786181 31-Jan-19 18772183 31-Dec-18 18686534 30-Nov-18 18585000 31-Aug-18 18584194 31-Aug-18 18582103 30-Sep-18 18582045 30-Sep-18 18557356 31-Aug-18 18510878 31-Jul-18 18523236 31-Jul-18 18772125 31-Dec-18 18686418 30-Nov-18 18647289 31-Oct-18 18452822 30-Jun-18 18450373 30-Jun-18 19033545 30-Apr-19 19004591 30-Apr-19 19004475 30-Apr-19 19004417 30-Apr-19 18927253 31-Mar-19 18915458 31-Mar-19 18915748 31-Mar-19 18915574 31-Mar-19 18915516 31-Mar-19 18845790 28-Feb-19 19052916 31-May-19 18976256 30-Apr-19 18976844 30-Apr-19 18976550 30-Apr-19 18895388 28-Feb-19 18895098 28-Feb-19 19031967 30-Apr-19 18976403 30-Apr-19 19063228 31-May-19 18941012 31-Mar-19 18957807 31-Mar-19 18896258 28-Feb-19 18865965 28-Feb-19 18885463 28-Feb-19 18845411 28-Feb-19 18984961 30-Apr-19 19032257 30-Apr-19 19031387 30-Apr-19 18928771 31-Mar-19 18928012 31-Mar-19 18846169 31-Jan-19 18866197 28-Feb-19 18846548 28-Feb-19 19052595 31-May-19 18957227 31-Mar-19 18956647 31-Mar-19 18866658 28-Feb-19 18886877 28-Feb-19 19031677 30-Apr-19 19076325 31-May-19 18941476 31-Mar-19 18895678 31-Mar-19 18915690 31-Mar-19 18915632 31-Mar-19 18866890 28-Feb-19 18866429 28-Feb-19 19052274 31-May-19 19065800 31-May-19 19004533 30-Apr-19 19004359 30-Apr-19 18941940 31-Mar-19 19051953 31-May-19 18976697 30-Apr-19 18895968 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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