Events

Recall of Device Recall iovera

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Myoscience 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
    65542
  • Event Risk Class
    Class 2
  • Event Number
    Z-1781-2013
  • Event Initiated Date
    2013-06-21
  • Event Date Posted
    2013-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119527
  • 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, surgical, cryogenic - Product Code GXH
  • Reason
    The outer box label of the product was labeled with a down revision label which did not include the us labeling requirements, specifically the symbol descriptors and also the "caution: federal law (usa) restricts this device to sale by or on the order of a physician." this product was previously labeled for eu distribution only.
  • Action
    Myoscience representatives visited both affected sites on June 14, 2013 and relabeled the product in person. Neither site had used the product and was unaffected by the relabeling. No formal communication was issued.

Device

Device Recall iovera
  • Model / Serial
    Serial Numbers: 100100, 100101, 100103
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution including CA and ID.
  • Product Description
    Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. || Product Usage: || The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
  • Manufacturer
    Myoscience Inc

Manufacturer

Myoscience Inc
  • Manufacturer Address
    Myoscience Inc, 1600 Seaport Blvd Suite 450, Redwood City CA 94063-5563
  • Manufacturer Parent Company (2017)
    MyoScience Inc.
  • Source
    USFDA