Events

Recall of Device Recall Langston Dual Lumen Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vascular Solutions, 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
    68489
  • Event Risk Class
    Class 1
  • Event Number
    Z-1981-2014
  • Event Initiated Date
    2014-05-27
  • Event Date Posted
    2014-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128032
  • 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, intravascular, diagnostic - Product Code DQO
  • Reason
    The inner catheter of some langston v2 dual lumen catheters have separated from the device hub during contrast pressure injections. this may require an intervention to retrieve the separated piece from the patient to prevent injury.
  • Action
    Vascular Solutions sent an Urgent Medical Device Removal letter dated May 23, 2014, to all affected consignees.The letter described the problem and the product affected by the recall. Advised consignees to remove affected devices and place them in a secure area. Requested consignees to fill and return the "VSI Account Inventory Form" to VSI's Customer Service Department by email customerservice@vasc.com or fax 763-656-4251. VSI will replace all returned devices. Customers with questions were advised to contact their local Vascular Solutions Account Manager. For questions regarding this recall call 763-656-4300.

Device

Device Recall Langston Dual Lumen Catheters
  • Model / Serial
    Lot Numbers: 569436, 569437, 569962 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
  • Product Description
    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Manufacturer Address
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA