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-2177-2016
  • 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=147578
  • 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: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.
  • 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 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.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

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