—#147575

Product

Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

FDA product code: HCG — Device, Neurovascular Embolization
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K113412, K153658
Affected lot / code info: MODEL Number: M0035442540: Lot Number/Expiration Date: 18820098 31-Jan-19 18819974 31-Jan-19 18809411 31-Jan-19 18809117 31-Jan-19 18768594 31-Dec-18 18736394 30-Nov-18 18654342 31-Oct-18 18554516 31-Aug-18 18489245 31-Jul-18 18416403 31-May-18 18393530 30-Apr-18 18820005 31-Jan-19 18778602 31-Dec-18 18735178 30-Nov-18 18760121 31-Dec-18 18583787 30-Sep-18 18583880 30-Sep-18 18778397 31-Dec-18 18778807 31-Dec-18 18760123 31-Dec-18 18469927 31-Jul-18 18455711 30-Jun-18 18441368 30-Jun-18 18820036 31-Jan-19 18809705 31-Jan-19 18760120 31-Dec-18 18654156 31-Oct-18 18606693 30-Sep-18 18521064 31-Jul-18 18808823 31-Jan-19 18808529 31-Jan-19 18787828 31-Jan-19 18758428 31-Dec-18 18654187 31-Oct-18 18654280 31-Oct-18 18583942 30-Sep-18 18521126 31-Jul-18 18469957 31-Jul-18 18831210 31-Jan-19 18758018 31-Dec-18 18654125 31-Oct-18 18521095 31-Jul-18 18462388 30-Jun-18 18456041 30-Jun-18 18455861 30-Jun-18 18830181 31-Jan-19 18820067 31-Jan-19 18787623 31-Jan-19 18787213 31-Jan-19 18654249 31-Oct-18 18606631 30-Sep-18 18606600 30-Sep-18 18819943 31-Jan-19 18787418 31-Jan-19 18768273 31-Dec-18 18767952 31-Dec-18 18654373 31-Oct-18 18654311 31-Oct-18 18554485 31-Aug-18 18489183 31-Jul-18 18462418 30-Jun-18 18455921 30-Jun-18 18441488 30-Jun-18 18441458 30-Jun-18 18416223 31-May-18 19052974 31-May-19 19052653 31-May-19 19043872 31-May-19 19013488 30-Apr-19 19069385 31-May-19 18943892 31-Mar-19 18913849 28-Feb-19 19068743 31-May-19 18976461 30-Apr-19 18893796 28-Feb-19 18894175 28-Feb-19 18870346 28-Feb-19 18885258 28-Feb-19 18992380 30-Apr-19 19028025 30-Apr-19 19080185 31-May-19 19052011 31-May-19 18960332 31-Mar-19 18998928 30-Apr-19 19013666 30-Apr-19 18870085 28-Feb-19 18951913 31-Mar-19 18944415 31-Mar-19 18944938 31-Mar-19 18914375 31-Mar-19 18913323 28-Feb-19 19028265 30-Apr-19 19028145 30-Apr-19 19043694 31-May-19 19069064 31-May-19 19013844 30-Apr-19 18951441 31-Mar-19 18929003 31-Mar-19 18913586 28-Feb-19 18870284 28-Feb-19 18870025 28-Feb-19 18992349 30-Apr-19 19027905 30-Apr-19 19043605 31-May-19 19043961 31-May-19 19068422 31-May-19 18999021 30-Apr-19 18998990 30-Apr-19 18976755 30-Apr-19 18976608 30-Apr-19 18893417 28-Feb-19 18943369 31-Mar-19 18992566 30-Apr-19 19052332 31-May-19 18976902 30-Apr-19 18951205 31-Mar-19 18894554 28-Feb-19 18905687 28-Feb-19 18886672 28-Feb-19 18875678 28-Feb-19 19080007 31-May-19 19013399 30-Apr-19 19013755 30-Apr-19 19013577 30-Apr-19 18952385 31-Mar-19 18905718 28-Feb-19 18914112 31-Mar-19 18870222 28-Feb-19 19043783 31-May-19 18927485 31-Mar-19 18952149 31-Mar-19 18951677 31-Mar-19 18928244 31-Mar-19 18870425 28-Feb-19 18870160 28-Feb-19.

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-06-06
Posted by FDA: 2016-07-11
Terminated: 2017-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147575. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.