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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Vascular Solutions Recalls Catheter Due to Defect

Vascular Solutions Recalls Catheter Due to Defect

July 7, 2014

Vascular Solutions is conducting a voluntary Class 1 nationwide recall of its Langston dual lumen catheters, due to the potential for the inner catheter to separate from the hub during use and travel through the patient's circulatory system.

“This may require a procedure to retrieve the separated piece from the patient’s vascular system,” according to a recall notice posted to the FDA’s website on July 3.

Minneapolis, Minn.-based Vascular Solutions alerted customers by letter on May 23, instructing them to return affected product to the company. Eighty-six percent of the affected inventory has been accounted for and returned, according to the devicemaker.

Vascular Solutions said it has received two reports of the inner catheter entering the patient's ventricle, resulting in surgical retrieval. No injuries have been reported, however.

The Langston dual lumen catheter is used to deliver contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This pressure measurement aids in determining transvalvular, intravascular and intraventricular pressure gradients.

The affected lots were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014. A total of 8,580 of the affected catheters were sold, with roughly 3,847 still unused in the field, the company said. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Medical Devices Commercial Operations

Upcoming Events

  • 19Jan

    Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management

  • 21Jan

    Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    U.S. Government Orders More Supplies of Regeneron’s COVID-19 Antibody Cocktail

  • Siemens Healthineers logo

    Siemens Healthineers COVID Test Gets Additional Sampling Method Clearance

  • COVID-19  Clinical Trial

    Synairgen Initiates Dosing in Late-Stage Trial of Inhaled COVID-19 Therapy

  • Verona Pharma logo

    Verona Pharma Ends Enrollment in Inhaler-Administered COVID-19 Drug Pilot

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing