Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Target Detachable Coils

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-2163-2016
Recall Event ID 74425
510(K)Number K113412  K153658  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Target Detachable Coils:
TARGET 360 NANO 1.5 MM X 3 CM
MODEL Number: M0035421530

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: M0035421530  Lot Number/Expiration Date: 18576579 31-Aug-18 18825794 31-Jan-19 18759372 31-Dec-18 18769642 31-Dec-18 18759430 31-Dec-18 18742312 30-Nov-18 18730158 30-Nov-18 18700332 30-Nov-18 18666315 31-Oct-18 18642494 31-Oct-18 18598589 30-Sep-18 18598705 30-Sep-18 18590702 30-Sep-18 18571949 31-Aug-18 18576695 30-Sep-18 18542073 31-Aug-18 18553555 31-Aug-18 18461134 30-Jun-18 18487818 31-Jul-18 18482418 31-Jul-18 18455339 30-Jun-18 18790369 31-Jan-19 18790079 31-Jan-19 18759314 31-Dec-18 18700274 30-Nov-18 18700158 30-Nov-18 18676997 30-Nov-18 18676591 30-Nov-18 18642436 31-Oct-18 18620147 30-Sep-18 18633863 31-Oct-18 18473146 30-Jun-18 18482417 31-Jul-18 18473260 30-Jun-18 18433320 30-Jun-18 18419555 31-May-18 18406749 31-May-18 18398515 31-May-18 18811376 31-Jan-19 18825968 31-Jan-19 18816588 31-Jan-19 18790427 31-Jan-19 18790253 31-Jan-19 18700448 30-Nov-18 18629577 31-Oct-18 18660541 31-Oct-18 18642610 31-Oct-18 18590760 30-Sep-18 18571717 31-Aug-18 18455453 30-Jun-18 18811260 31-Jan-19 18811202 31-Jan-19 18811144 31-Jan-19 18790137 31-Jan-19 18769874 31-Dec-18 18769990 31-Dec-18 18742196 31-Dec-18 18742080 30-Nov-18 18598763 30-Sep-18 18590644 30-Sep-18 18571601 31-Aug-18 18524506 31-Jul-18 18433263 30-Jun-18 18817914 31-Jan-19 18811434 31-Jan-19 18660773 31-Oct-18 18642320 31-Oct-18 18642262 31-Oct-18 18553671 31-Aug-18 18811086 31-Jan-19 18714014 30-Nov-18 18676707 30-Nov-18 18666373 31-Oct-18 18666257 31-Oct-18 18620205 30-Sep-18 18619915 30-Sep-18 18461647 30-Jun-18 18433149 30-Jun-18 18826490 31-Jan-19 18826142 31-Jan-19 18825446 31-Jan-19 18817251 31-Jan-19 18790021 31-Jan-19 18776885 31-Dec-18 18742022 30-Nov-18 18730042 30-Nov-18 18676649 30-Nov-18 18660599 31-Oct-18 18619857 30-Sep-18 18629635 31-Oct-18 18590818 30-Sep-18 18571427 31-Aug-18 18541957 31-Aug-18 18391790 30-Apr-18 18398230 31-May-18 18826316 31-Jan-19 18825620 31-Jan-19 18811318 31-Jan-19 18714188 30-Nov-18 18700216 30-Nov-18 18676881 30-Nov-18 18660657 31-Oct-18 18629519 31-Oct-18 18571369 31-Aug-18 18576637 31-Aug-18 18542189 31-Aug-18 19055983 31-May-19 19030191 30-Apr-19 19030249 30-Apr-19 19044572 31-May-19 19013341 30-Apr-19 19065510 31-May-19 18998464 30-Apr-19 19013697 30-Apr-19 19013608 30-Apr-19 18964020 31-Mar-19 18978422 30-Apr-19 18977726 30-Apr-19 18933278 31-Mar-19 18914201 31-Mar-19 18868972 28-Feb-19 18881876 28-Feb-19 18848857 28-Feb-19 18849495 28-Feb-19 18849089 28-Feb-19 19056041 31-May-19 19065394 31-May-19 18947542 31-Mar-19 18979118 30-Apr-19 18978190 30-Apr-19 18977958 30-Apr-19 18933104 31-Mar-19 18932988 31-Mar-19 18947716 31-Mar-19 18897756 31-Mar-19 18869318 28-Feb-19 18882108 28-Feb-19 18849321 28-Feb-19 18882572 28-Feb-19 19030365 30-Apr-19 19030133 30-Apr-19 19044688 31-May-19 19065278 31-May-19 18867934 28-Feb-19 18868279 28-Feb-19 18882224 28-Feb-19 18849205 28-Feb-19 19056099 31-May-19 19055925 31-May-19 19044746 31-May-19 19044456 31-May-19 19013786 30-Apr-19 19013519 30-Apr-19 18964484 31-Mar-19 18953296 31-Mar-19 18948238 31-Mar-19 18947368 31-Mar-19 18896901 28-Feb-19 18913412 28-Feb-19 18882456 28-Feb-19 19055809 31-May-19 19044630 31-May-19 18998522 30-Apr-19 19065336 31-May-19 18964948 30-Apr-19 18933046 31-Mar-19 18933162 31-Mar-19 18897585 31-Mar-19 18914464 31-Mar-19 18881992 28-Feb-19 19081044 31-May-19 19030307 30-Apr-19 19044514 31-May-19 19065626 31-May-19 19065568 31-May-19 19013430 30-Apr-19 19065684 31-May-19 18948064 31-Mar-19 18963556 31-Mar-19 18913675 31-Mar-19 19056157 31-May-19 19081659 31-May-19 19030075 30-Apr-19 19065452 31-May-19 18947194 31-Mar-19 18933220 31-Mar-19 18897414 28-Feb-19 18913938 31-Mar-19 18868628 28-Feb-19 18867586 28-Feb-19 18882340 28-Feb-19 18848625 28-Feb-19 19055751 31-May-19 19080839 31-May-19 19030017 30-Apr-19 18978654 30-Apr-19 18848973 28-Feb-19 18848741 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
-
-