Events

Recall of Device Recall iovera Smart Tip

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
    71650
  • Event Risk Class
    Class 2
  • Event Number
    Z-2201-2015
  • Event Initiated Date
    2015-07-01
  • Event Date Posted
    2015-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138539
  • 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 expiration date on the outer box label and the pouch label for the iovera smart tip product is incorrect. instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
  • Action
    Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.

Device

Device Recall iovera Smart Tip
  • Model / Serial
    Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
  • Product Description
    iovera 155 Smart Tip; || Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) || iovera Smart Tips are individually packaged in Tyvek PET pouches, which are || then packaged into 5 or 10 pack boxes and shipper boxes. || Product Usage: Cyrogenic Surgical Device The myoscience iovera device 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 iovera device is not indicated for treatment of central nervous system tissue
  • Manufacturer
    Myoscience Inc

Manufacturer

Myoscience Inc
  • Manufacturer Address
    Myoscience Inc, 46400 Fremont Blvd, Fremont CA 94538-6469
  • Manufacturer Parent Company (2017)
    MyoScience Inc.
  • Source
    USFDA