—#147578

Product

Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 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:M0035443560: Lot Number/Expiration Date: 18736425 31-Dec-18 18521457 31-Jul-18 18838703 31-Jan-19 18703233 30-Nov-18 18443288 30-Jun-18 18735209 30-Nov-18 18659056 31-Oct-18 18781251 31-Jan-19 18801665 31-Jan-19 18747459 31-Dec-18 18802980 31-Jan-19 18659087 31-Oct-18 18649087 31-Oct-18 18536525 31-Aug-18 19046694 31-May-19 19047725 31-May-19 18875709 28-Feb-19 18987089 30-Apr-19 19006438 30-Apr-19 18959391 31-Mar-19 18936943 31-Mar-19 19022830 30-Apr-19 18984771 30-Apr-19 18922696 31-Mar-19 18898321 28-Feb-19 19061363 31-May-19 18853805 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 #147578. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.