• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    SurgVision's EXPLORER AIR II Gets FDA OK

    Brainomix's Flagship Stroke AI Imaging Software OK'ed

    Cue Health Nabs EUA for Molecular Mpox Test

    FDA Clears Viz.ai's AI Algorithm for Abdominal Aortic Aneurysm

    Etiometry's IVCO2 Index Receives EU, Health Canada Authorization
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    CR-SOP Neurotechnology Helps to Achieve ‘Sound’ Sleep

    Inside the Hospital Value Analysis Committee

    Face Time: Why Getting Engineers Out of the Lab Is Good for Business

    Common Paratubing Pitfalls and How to Avoid Them

    During Times of Uncertainty, Create Business Value with an Optimized Workforce
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    LEMO USA Inc.

    Cirtec Medical

    Forefront Medical Technology

    JBC Technologies

    NDH Medical Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing Medical Devices Revolutionized Manufacturing

    5 Current Trends in Medical Device Security

    How Advanced Sensors Improve Design & Functionality of Respiratory Care Equipment

    Sourcing Silicone Parts: Injection Mold or 3D Print?

    Cybersecurity in Healthcare: Getting on the Right Track
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Cirtec Medical

    Forefront Medical Technology

    JBC Technologies

    NDH Medical Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Designates Medtronic Action as Class I Recall

    Company had initiated voluntary field action related to its HVAD System Controllers and DC Adapters.

    FDA Designates Medtronic Action as Class I Recall
    Medtronic plc04.19.17
    Medtronic plc has announced that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.
     
    Medtronic began notifying clinicians outside of the United States in March 2017 about updated HVAD System Controllers and DC Adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017.
     
    The updated controller includes enhancements designed to address the potential safety issues identified in the previously communicated notices, including:
     
    • Strengthened power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins
    • Functionality designed to monitor internal battery performance and sound an alert when the internal battery is nearing depletion
    • Fedesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids
     
    In addition, the updated controller introduces upgraded internal circuitry designed to improve overall device reliability.
     
    In April 2015 and April 2016, Medtronic notified clinicians about potential safety issues with the current HVAD System Controller that could lead to possible injury and death due to worn alignment guides, internal "double disconnect (no power) alarm" battery failure, and loose power and data connectors.
     
    With the introduction of the updated controller, Medtronic has begun to remove current HVAD Controllers (product codes 1400,1401US and 1407US) in select geographies, including the U.S. Medtronic also has begun to remove the related adapters (product code 1435), Instructions for Use, Patient Manuals and Emergency Responder Guides.
     
    As part of these activities, Medtronic has provided the following recommendations to physicians:
     
    • Before the updated controller will be distributed to hospitals, clinicians must complete required training on the updated controller and updated product labeling, including the Instructions for Use and Patient Manual.
    • Following training and the receipt of the updated controllers in hospital inventory, clinicians are requested to quarantine and replace patients' primary and backup HVAD Controllers and DC adapters under clinical supervision and at a hospital where patient support equipment is available.  
    • While Medtronic recommends that HVAD Controllers be exchanged, clinicians should weigh the benefits of the updated controller against the risks of a controller exchange procedure.  
    • When clinicians determine a controller exchange is appropriate, they will notify patients who should promptly schedule a controller exchange as soon as the updated controllers are available.
    • Trained hospital staff must educate patients on using the updated controller.
     
    Patients with questions about this announcement should contact their physicians or ventricular assist device (VAD) coordinator at their hospital center.
     
    Adverse reactions or quality problems experienced with the use of this device may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
     
    • Complete and submit the report online: www.fda.gov/medwatch/report.htm  
    • Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call +1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to +1-800-FDA-0178
    Related Searches
    • 2015
    • u.s. food and drug administration
    • vad
    • labeling
    Suggested For You
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board
    Bright Future Ahead for Renal Denervation Bright Future Ahead for Renal Denervation
    iCAD Signs Global Distribution Agreement With Sectra iCAD Signs Global Distribution Agreement With Sectra
    Cala Health Expands its Executive Team Cala Health Expands its Executive Team
    Outset Medical Appoints Katie Szyman to its Board Outset Medical Appoints Katie Szyman to its Board
    Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027 Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027
    Substantial Growth Predicted for Global Ventilators Market Substantial Growth Predicted for Global Ventilators Market
    Fluid Management System Market to be Worth $23.2 Billion By 2028 Fluid Management System Market to be Worth $23.2 Billion By 2028
    Receiving FDA Approval in Under One Month Receiving FDA Approval in Under One Month
    The Future of AI and OR Medical Devices The Future of AI and OR Medical Devices
    The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology
    Medtronic Starts Construction on New Innovation Center Medtronic Starts Construction on New Innovation Center
    Expanded FDA Approval for Medtronic Expanded FDA Approval for Medtronic's Arctic Front Cryoablation Catheter

    Related Breaking News

    • Medical Devices Market to Top $671.49 Billion by 2027

      Medical Devices Market to Top $671.49 Billion by 2027

      Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.
      Precedence Research 09.16.21

    • RapidPulse Closes $15 Million Series A Financing

      RapidPulse Closes $15 Million Series A Financing

      Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.
      Globe Newswire 09.10.21

    • Luis J. Malavé Joins Integrity Applications Board

      Luis J. Malavé Joins Integrity Applications Board

      New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.
      Globe Newswire 09.08.21


    • Bright Future Ahead for Renal Denervation

      Bright Future Ahead for Renal Denervation

      No devices yet approved in the United States for the high blood pressure treatment.
      GlobalData 09.02.21

    • Digital Health
      iCAD Signs Global Distribution Agreement With Sectra

      iCAD Signs Global Distribution Agreement With Sectra

      Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.
      Globe Newswire 08.19.21

    Loading, Please Wait..

    Trending
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • The Future Of Biomedical Engineering Advancements
    • A New Approach To Post-Market Surveillance
    • Philips Names New Supervisory Board Chairman
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    Breaking News
    • SurgVision's EXPLORER AIR II Gets FDA OK
    • Brainomix's Flagship Stroke AI Imaging Software OK'ed
    • Cue Health Nabs EUA for Molecular Mpox Test
    • FDA Clears Viz.ai's AI Algorithm for Abdominal Aortic Aneurysm
    • Etiometry's IVCO2 Index Receives EU, Health Canada Authorization
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Sensing Technology Drives the Future of Medical Care
    • New and Developing Diabetes Technologies Offer 'Sweet Relief'
    • Discussing Matters of Substance in Medtech Materials
    • Medical Device Testers Are Caught Up in a Whirlwind
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets
    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement
    NOW Tests Bromelain Supplements Purchased on Amazon
    Coatings World

    Latest Breaking News From Coatings World

    Norwegian Cruise Line Goes Biocide-Free with Nippon Paint Marine's AQUATERRAS
    ChemQuest Names Carla McBain a Director
    BASF Invests in Expansion of Polymer Dispersions Plant in Daya Bay, China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    SurgVision's EXPLORER AIR II Gets FDA OK
    Brainomix's Flagship Stroke AI Imaging Software OK'ed
    Cue Health Nabs EUA for Molecular Mpox Test
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Diabeloop, Novo Nordisk Partner on Next-Gen Insulin Pens
    Jost Chemical Increases Manufacturing Capacity of Sodium Caprate, Sodium Caprylate
    Stevanato Group, Thermo Fisher Partner to Bring On-Body Delivery System to Market
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Mary Kay Earns Forest Stewardship Council Certification
    IPSY Teams Up with Anastasia Soare for Icon Box
    Tattoo Skincare Brand Mad Rabbit Raises $10 Million—Mark Cuban is an Investor
    Happi

    Latest Breaking News From Happi

    Divi Appoints Erica Randerson Vice President of E-Commerce
    Past Estée Lauder Executive Joins Provectus Algae as Cosmetics Advisor
    Mary Kay Inc. Receives Forest Stewardship Council Certification
    Ink World

    Latest Breaking News From Ink World

    MNYPIA Names John Hrdlick 2023 Anthony Mauriello Award Honoree
    Amcor’s Sustainability Commitment Receives ‘AA’ Rating by MSCI
    HP Debuts the HP Indigo 200K Digital Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Jones Healthcare invests in Gallus Labelmaster from Heidelberg
    Innovia presents sustainable label films at Interpack
    Creation helps Whitworths with solvent-free flexible packaging prepress
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Ranks Third Among 100 Most Sustainable Companies
    Weekly Recap: TerraCycle Launches Diaper Program, Ahlstrom to Divest or Shutter Stenay Plant & More
    Mativ Names CFO
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Loci Orthopaedics Earns New Patent for Thumb Base Joint Implant System
    Study: Running Does Not Increase Arthritis Risk
    Study Highlights the Positive Clinical Outcomes of Medacta’s MySpine System
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Tekscan Launches New High-Speed Tire Pressure Testing System
    Schreiner PrinTrust Produces RFID-Enabled Labels for seventhings
    LG Display’s 65-Inch OLED TV Panel Receives Carbon Footprint Certification

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login