Events

Recall of GDC10 360 SOFT 3mm x 6cm SR:

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
    69669
  • Event Risk Class
    Class 2
  • Event Number
    Z-0478-2015
  • Event Initiated Date
    2014-10-22
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131298
  • 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
    Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
  • Action
    Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters request that users take the following actions: 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: a. Fax it to: 1-866-876-4355 or b. E-mail a copy to: NeuroComplaints@stryker.com c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Stryker Customer Service reps will contact customers to arrange for replacement. Any returned product will be quarantined and destroyed.

Device

GDC10 360 SOFT 3mm x 6cm SR:
  • Model / Serial
    Model M003347306SRO, Lot number: 14467382; Exp. May 2014.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of: VA, NH, OH and TX.
  • Product Description
    GDC-10 360 SOFT 3mm x 6cm SR ; || GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's || general medical condition - are considered by the treating neurosurgical team to be || a) very high risk for management by traditional operative techniques, or b) inoperable
  • Manufacturer
    Stryker Neurovascular

Manufacturer

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