We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » LivaNova Upgrades Heart Device to Cut Risk of Infection

LivaNova Upgrades Heart Device to Cut Risk of Infection

October 19, 2018

A heart device manufacturer says it has upgraded the machine to cut down on the risk that it may be spreading bacteria.

Germany’s LivaNova makes the Stockert 3T Heater-Cooler System. The company says that the machine — typically used to regulate body temperature during heart surgery — might have been spreading aerosolized bacteria through its water tanks.

LivaNova tells the FDA that it has developed a vacuum canister and changed the design of 3T’s internal sealing system. The company hopes the changes will cut down on the risk of secondary infections but acknowledges that they won’t eliminate the risk altogether.

The company is also dispatching representatives to contact 3T customers and schedule the upgrades. Any devices in the LivaNova’s deep cleaning centers will be upgraded on-site, the FDA said.

View today's stories

Medical Devices Postmarket Safety

Upcoming Events

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • BioVentrix gets Expanded Access Approval for Left Ventricle Support System

  • FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer

  • FDA Issues Update on LivaNova Recall of Blood Pumping System

  • EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing