—#147555

Product

Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 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: M0035431030; Lot Number/Expiration Date: 18801491 31-Jan-19 18757273 31-Dec-18 18709428 30-Nov-18 18602133 30-Sep-18 18523870 31-Jul-18 18802806 31-Jan-19 18664601 31-Oct-18 18569137 31-Aug-18 18517839 31-Jul-18 18486090 31-Jul-18 18842022 31-Jan-19 18651923 31-Oct-18 18651865 31-Oct-18 18607288 30-Sep-18 18518071 31-Jul-18 18774611 31-Dec-18 18762227 31-Dec-18 18637042 31-Oct-18 18564861 31-Aug-18 18843756 28-Feb-19 18842889 31-Jan-19 18781019 31-Jan-19 18651981 31-Oct-18 18546861 31-Aug-18 18447942 30-Jun-18 18830688 31-Jan-19 18815198 31-Jan-19 18814328 31-Jan-19 18736978 30-Nov-18 18592210 30-Sep-18 18517955 31-Jul-18 18414488 31-May-18 18829659 31-Jan-19 18583312 31-Aug-18 18984903 30-Apr-19 19050397 31-May-19 18883354 28-Feb-19 18911821 31-Mar-19 19041285 30-Apr-19 18944244 31-Mar-19 18922785 31-Mar-19 18902333 28-Feb-19 18911418 31-Mar-19 18857263 28-Feb-19 18973207 30-Apr-19 19041807 30-Apr-19 19065916 31-May-19 19063344 31-May-19 18901691 28-Feb-19 19074243 31-May-19 19049355 31-May-19 19042329 31-May-19 19005113 30-Apr-19 18944767 31-Mar-19 18973553 30-Apr-19 18943198 31-Mar-19 18943721 31-Mar-19 19042851 31-May-19 18855184 28-Feb-19 19048313 31-May-19 18972861 30-Apr-19 18953849 31-Mar-19 18912224 31-Mar-19 19005171 30-Apr-19 18902975 28-Feb-19 18912627 31-Mar-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 #147555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.