Events

Recall of Device Recall Electrical Venous Occluder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, 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
    56139
  • Event Risk Class
    Class 2
  • Event Number
    Z-2075-2010
  • Event Initiated Date
    2010-06-18
  • Event Date Posted
    2010-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92730
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Although accessories were designed for use with two models, the hlm c5 and the hlm s5, the submission that included references to the mast roller pump, b-care5, and the electrical venous line occluder accessories covered the new hlm s5 system. the three accessories were not cleared for use with the hlm c5.
  • Action
    The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.

Device

Device Recall Electrical Venous Occluder
  • Model / Serial
    Serial number: 12K01077.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, PA, TN.
  • Product Description
    Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA