Events

Recall of Device Recall Guardian II Hemostasis Valve

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
    73553
  • Event Risk Class
    Class 1
  • Event Number
    Z-1275-2016
  • Event Initiated Date
    2016-03-04
  • Event Date Posted
    2016-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144454
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • Reason
    Vascular solutions became aware of a potential problem with the click version of the guardian ii hemostasis valves. the low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
  • Action
    Consignees were sent on 3/4/2016 via first class mail a Vascular Solutions "Urgent Medical Device Recall" letter dated March 3, 2016. The letter described the problem and the product involved in the recall. It included the "Immediate Action Required of Customer / User" which instructed the customer to identify the product, remove it from inventory, place it in a secure area, and complete and return the VSI Account Inventory Form to the Customer Service Department.

Device

Device Recall Guardian II Hemostasis Valve
  • Model / Serial
    Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV. OUS: Ireland
  • Product Description
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. || Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
  • 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