—#147547

Product

Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 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: M0035431010 Lot Number/Expiration Date: 18784731 31-Jan-19 18767279 31-Dec-18 18685490 30-Nov-18 18592036 30-Sep-18 18818328 31-Jan-19 18723284 30-Nov-18 18630215 31-Oct-18 18601959 30-Sep-18 18414374 31-May-18 18748453 31-Dec-18 18730570 30-Nov-18 18606940 30-Sep-18 18403443 31-May-18 18818502 31-Jan-19 18796245 31-Jan-19 18627513 31-Oct-18 18601901 30-Sep-18 18581353 30-Sep-18 18484777 31-Jul-18 18818676 31-Jan-19 18777759 31-Dec-18 18484661 31-Jul-18 18429414 30-Jun-18 18801963 31-Jan-19 18803278 31-Jan-19 18786355 31-Jan-19 18776711 31-Dec-18 18767778 31-Dec-18 18723052 30-Nov-18 18539797 31-Aug-18 18417674 31-May-18 18831860 31-Jan-19 18818850 31-Jan-19 18739085 30-Nov-18 18833082 31-Jan-19 18748163 31-Dec-18 18738163 30-Nov-18 18602017 30-Sep-18 18581469 31-Aug-18 18543905 31-Aug-18 18450658 30-Jun-18 19002735 30-Apr-19 18941882 31-Mar-19 18941418 31-Mar-19 18930269 31-Mar-19 18894264 28-Feb-19 18893885 28-Feb-19 18885637 28-Feb-19 18957343 31-Mar-19 18956763 31-Mar-19 18940954 31-Mar-19 18857373 28-Feb-19 18975521 30-Apr-19 18975084 30-Apr-19 18847507 28-Feb-19 18930614 31-Mar-19 18847275 31-Jan-19 19002909 30-Apr-19 18929924 31-Mar-19 18847333 31-Jan-19 19062880 31-May-19 19002851 30-Apr-19 19002677 30-Apr-19 18974210 30-Apr-19 18930959 31-Mar-19 18906932 31-Mar-19 19046992 31-May-19 19002793 30-Apr-19 18893506 28-Feb-19 18887051 28-Feb-19 18847391 28-Feb-19 18984787 30-Apr-19 19037618 31-May-19 19064752 31-May-19 18894643 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 #147547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.