Events

Recall of Device Recall Merci Retriever

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

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
    69119
  • Event Risk Class
    Class 2
  • Event Number
    Z-2598-2014
  • Event Initiated Date
    2014-06-25
  • Event Date Posted
    2014-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129669
  • 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
    Catheter, thrombus retriever - Product Code NRY
  • Reason
    Merci retrievers were shipped to us customers past their expiration date, even though they were labeled with the correct expiration date.
  • Action
    Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of the response form, a representative will contact the firm to arrange for return and/or credit for the devices. Fax it to 1-866-876-4355. For further questions please call ( 650) 810-1707 Ext. 1716.

Device

Device Recall Merci Retriever
  • Model / Serial
    Model Number 90109; Lot number 35695
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of PA, CA, TX, NM, and OH.
  • Product Description
    Merci Retriever || Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Manufacturer Address
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA