Events

Recall of Stockert HeaterCooler System 3T

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

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
    80072
  • Event Risk Class
    Class 2
  • Event Number
    Z-1901-2018
  • Event Initiated Date
    2018-04-20
  • Event Date Posted
    2018-05-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164360
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Reason
    Firm is notifying customers that the deep-cleaning service is now available in the united states. stockert heater-cooler system 3t devices are suspected of microbial contamination and may contain visible biofilm.
  • Action
    On 04/20/2018, a Medical Device Correction notice was sent to customers informing them to return devices less than ten years old. Returned devices will receive a deep cleaning service, which will reduce microbial contamination to HPC < 100 CFU/ml of water and NTM < 1 CFU/100ml.

Device

Stockert HeaterCooler System 3T
  • Model / Serial
    Serial #: a) 16S10743 - 6S11708  b) 16S10772 - 16S16840  C) 16S10958 - 16S16847
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,
  • Product Description
    Sorin Stockert Heater-Cooler System 3T, || a) Item #: 16-02-81, 240 v/60 Hz; || b) Item #: 16-02-82, 208 v/60 Hz; || c) Item #: 16-02-85, 120 v/60 Hz
  • Manufacturer
    LivaNova USA

Manufacturer

LivaNova USA
  • Manufacturer Address
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA