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-2171-2016
  • 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=147560
  • 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: 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.
  • 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 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.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

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