—#147560

Product

Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 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: M0035431540: Lot Number/Expiration Date: 18843121 28-Feb-19 18842254 28-Feb-19 18752256 31-Dec-18 18637622 31-Oct-18 18531974 31-Aug-18 18450202 30-Jun-18 18765704 31-Dec-18 18749439 31-Dec-18 18748627 31-Dec-18 18546175 31-Aug-18 18546117 31-Aug-18 18556378 31-Aug-18 18538344 31-Aug-18 18749033 31-Dec-18 18602307 30-Sep-18 18532032 31-Jul-18 18802864 31-Jan-19 18797083 31-Jan-19 18794216 31-Jan-19 18812672 31-Jan-19 18637738 31-Oct-18 18607230 31-Oct-18 18637680 31-Oct-18 18449404 30-Jun-18 18794100 31-Jan-19 18776421 31-Dec-18 18602365 30-Sep-18 18581643 30-Sep-18 18801549 31-Jan-19 18737036 31-Dec-18 18602249 30-Sep-18 18486380 31-Jul-18 18486322 31-Jul-18 19086644 31-May-19 18941592 31-Mar-19 19086586 31-May-19 18973495 30-Apr-19 19004069 30-Apr-19 18859100 28-Feb-19 18972803 30-Apr-19 19056273 31-May-19 19062764 31-May-19 19003895 30-Apr-19 18973149 30-Apr-19 18956009 31-Mar-19 18893301 28-Feb-19 18894059 28-Feb-19 18860564 28-Feb-19 19003547 30-Apr-19 18955103 31-Mar-19 18942056 31-Mar-19 18886614 28-Feb-19 18894438 28-Feb-19 18941128 31-Mar-19 19083403 31-May-19 18862068 28-Feb-19 18885200 28-Feb-19 19003721 30-Apr-19 19064636 31-May-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 #147560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.