• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Top News
    Alleviant's Transcatheter Tech Obtains Breakthrough Status

    Signia Appoints New President

    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

    MedAcuity, Fathom Partner on Human Factors Engineering Services
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Creganna Medical, part of TE Connectivity

    K-Tube Technologies

    Unicep

    PTI Engineered Plastics Inc.

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Element

    maxon

    Unicep

    Medicoil
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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

    Medtronic Recalls StealthStation Auto-Registration Feature Over Inaccuracies

    Inaccuracies caused by minor patient movements during auto-registration; 11 injuries reported.

    Related CONTENT
    • CHF Solutions Appoints CEO
    • Quantitative Transmission Ultrasound Outperforms Mammography
    • Katena Products Welcomes New CEO
    • Medtronic’s Mike Coyle to Lead iRhythm
    • Medtronic's OsteoCool Procedure Shows Significant Pain Relief in Cancer Patients
    U.S. Food and Drug Administration06.01.20
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
     
    Recalled Product
     
    • Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License
    • Distribution Dates: February 1, 2016 to May 1, 2019
    • Devices Recalled in the U.S.: 54 consignees were notified with affected product.
    • Date Initiated by Firm: August 9, 2019
     
    The StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System provides images of a patient’s brain to help surgeons navigate surgical tools and implants used during a deep brain stimulation (DBS) procedure.
     
    Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device system. This may provide inaccurate registration data which could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures. This could result in serious or life-threatening patient harm.
     
    As of June 2020, a total of 33 medical device reports were identified: 22 related to device malfunction and 11 related to injuries.
     
    Healthcare providers using the StealthStation DBS Software in conjunction with the NexFrame Stereotactic System during a DBS procedure and all patients who undergo a DBS procedure with the use of the technology using the auto-registration workflow may be affected.
     
    On August 9, 2019, Medtronic sent Urgent Medical Device Correction letters to all affected customers. The letter advised physicians to weigh the benefits vs. risks of fiducial-based or fiducial-less registration methods and provided the following instructions:
     
    Following the O-arm auto-registration step, but prior to using the StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System for intraoperative navigation:
     
    1. Assess navigational accuracy by verifying the accuracy of the registration on several known anatomical landmarks, as described in the indications for use, before using the registration for navigation.
    2. Use the StealthMerge functionality in the software, as described in the indications for use, to compare the actual location of the cannula or lead to the surgical plan.
    3. Use the planning functionality in the software, as described in the indications for use, to compare the cannula to planned trajectory. This can be accomplished by making an additional plan along the axis of the cannula to evaluate cannula position.
     
    Medtronic has also added instructions to the label on how to use the device and software. In addition, Medtronic has an updated training program to inform physicians of the inaccuracies due to undetected patient motion that resulted in this recall. FDA is continuing to work with Medtronic to determine whether additional mitigations may be needed.
     
    Health care professionals and distributors with questions about this recall should contact Medtronic and call 1-888-826-5603 or email rs.navtechsupport@medtronic.com.
    Related Searches
    • Software & IT
    • Neurological
    Related Knowledge Center
    • Neurological
    • Software & IT
    Suggested For You
    Medtech Matters: Medtronic Medtech Matters: Medtronic's Robotic Surgery Status
    CHF Solutions Appoints CEO CHF Solutions Appoints CEO
    Quantitative Transmission Ultrasound Outperforms Mammography Quantitative Transmission Ultrasound Outperforms Mammography
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO
    Medtronic’s Mike Coyle to Lead iRhythm Medtronic’s Mike Coyle to Lead iRhythm
    Medtronic Medtronic's OsteoCool Procedure Shows Significant Pain Relief in Cancer Patients
    Preparing Your Design Controls for FDA Approval Preparing Your Design Controls for FDA Approval
    Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine
    Setting the Standard: Protective Nanocoatings for Today Setting the Standard: Protective Nanocoatings for Today's Medtech
    Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market
    Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market
    Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027 Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027
    Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
    How Design Controls Can Prevent Medical Device Recalls How Design Controls Can Prevent Medical Device Recalls
    Medtronic Launches InPen with Real-Time Guardian Connect CGM Data Medtronic Launches InPen with Real-Time Guardian Connect CGM Data

    Related Breaking News

    • Neurological
      Boston Scientific

      Boston Scientific's Vercise Genus DBS Earns FDA Approval

      Fourth-generation DBS portfolio features full-body MR conditional devices.
      Sam Brusco, Associate Editor 01.22.21

    • Digital Health | Software & IT
      Philips Buys Capsule Technologies in $635M Deal

      Philips Buys Capsule Technologies in $635M Deal

      Capsule offers vendor-neutral Medical Device Information Platform with an SaaS business model.
      GlobeNewswire 01.19.21

    • Neurological
      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.
      Business Wire 01.14.21


    • Neurological
      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson

      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

      First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.
      PR Newswire 01.14.21

    • Digital Health | Software & IT
      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."
      U.S. Food and Drug Administration 01.13.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21


    • Diagnostics | Neurological
      FDA OKs Abbott

      FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

      Produces a result within 15 minutes after a plasma sample is inserted.
      Abbott Laboratories 01.11.21

    • Neurological
      BioSerenity Achieves FDA Clearance for Wearable Device System

      BioSerenity Achieves FDA Clearance for Wearable Device System

      Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.
      PRNewswire 01.07.21

    • Software & IT
      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Companies developing an enhanced integrated workflow solution designed to provide superior infection prevention and practice optimization.
      Business Wire 01.07.21


    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21

    • Patient Monitoring | Software & IT
      AI Metrics

      AI Metrics' Liver Imaging Software Earns FDA Nod

      Early-stage startup approved for low-cost, low-risk, non-invasive procedures for chronic liver disease patients.
      University of Alabama at Birmingham 12.09.20

    • Diagnostics | Software & IT
      FDA OKs Hologic

      FDA OKs Hologic's Genius AI Breast Cancer Detection Software

      New deep-learning algorithm helps radiologists detect breast cancers in their early stages.
      Business Wire 12.01.20


    • Diagnostics | Software & IT
      RSNA News: Royal Philips Introduces IntelliSpace Portal 12

      RSNA News: Royal Philips Introduces IntelliSpace Portal 12

      A next-gen Advanced Visualization Workspace with AI capabilities.
      Royal Philips 11.30.20

    • Software & IT
      GE Healthcare Launches X-ray AI for COVID-19 Patients

      GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

      A necessary and important step when ventilating critically ill COVID-19 patients.
      Business Wire 11.23.20

    • Neurological

      'Smart Wrap' Implant May Help Improve Bladder Control

      Delivers light to the bladder for optogenetic neuromodulation of underactive bladders.
      Penn State 11.12.20


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • Alleviant's Transcatheter Tech Obtains Breakthrough Status
    • Signia Appoints New President
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • MedAcuity, Fathom Partner on Human Factors Engineering Services
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    Clinical Evidence Suggests Potential Oral Benefits for Curcumin Extract
    Oleic Acid Possibly Implicated in MS Pathology
    NIH Study Compares Low-Fat, Plant-Based to Low-Carb, Animal-Based Diet
    Coatings World

    Latest Breaking News From Coatings World

    APV Engineered Coatings Reflects on 2020
    LINE-X Launches Dealer Program with International Truck
    BCF CEO to Chair Royal Society of Chemistry Surface Coatings Interest Group
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Signia Appoints New President
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    Humanigen, Emergent Enter Covid-19 Partnership
    Samsung Bioepis Opens New Headquarters
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Fitglow Beauty Wins Big at Annual Dirty Thinker’s Choice Awards
    e.l.f. Cosmetics Unveils Mint Melt Collection
    Estée Lauder Companies Updates Supply Chain Leadership
    Happi

    Latest Breaking News From Happi

    Wellness Brand Partners with Kate Upton
    Curcumin's Role in Oral Care
    Degree Launches Bath and Shower Range
    Ink World

    Latest Breaking News From Ink World

    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    VPF launches deep-freeze adhesive
    ProMach strengthens flexible packaging business
    Gallus planning virtual event for March
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    Imec Technology Taking Off to Space
    Osram in Top 25 of World’s 100 Most Sustainable Companies

    Copyright © 2021 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