Events

Recall of Device Recall Target Detachable Coils

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Neurovascular.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74425
  • Event Risk Class
    Class 2
  • Event Number
    Z-2175-2016
  • Event Initiated Date
    2016-06-06
  • Event Date Posted
    2016-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147576
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, neurovascular embolization - Product Code HCG
  • Reason
    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.
  • Action
    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.

Device

Device Recall Target Detachable Coils
  • Model / Serial
    MODEL Number:M0035443040 :  Lot Number/Expiration Date: 18442838 30-Jun-18 18442388 30-Jun-18 18490600 31-Jul-18 18831276 31-Jan-19 18760116 31-Dec-18 18760119 31-Dec-18 18584035 30-Sep-18 18470827 31-Jul-18 18442358 30-Jun-18 18830247 31-Jan-19 18470767 30-Jun-18 18470857 31-Jul-18 18800019 31-Jan-19 18760117 31-Dec-18 18568317 31-Aug-18 18462748 30-Jun-18 18443108 30-Jun-18 18442178 30-Jun-18 18568224 31-Aug-18 18490538 31-Jul-18 18462838 30-Jun-18 18568193 31-Aug-18 18584004 30-Sep-18 18490662 31-Jul-18 18442688 30-Jun-18 19066241 31-May-19 19035290 31-May-19 18902944 28-Feb-19 18877825 28-Feb-19 18973721 30-Apr-19 18846664 31-Jan-19 19081717 31-May-19 19026562 30-Apr-19 18973029 30-Apr-19 18876957 28-Feb-19 18905865 28-Feb-19 19027086 30-Apr-19 19080897 31-May-19 19063669 31-May-19 18845906 31-Jan-19 18845527 31-Jan-19 19026038 30-Apr-19 18902302 28-Feb-19 18846285 31-Jan-19 19081102 31-May-19 18901660 28-Feb-19.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    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.
  • Product Description
    Target Detachable Coils: || TARGET 360 NANO 3MM X 4CM || MODEL Number:M0035443040 || Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Manufacturer Address
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA