Medical Devices

Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect

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:

  • Guardian II Hemostasis Valve
  • Model number: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211
  • Lot numbers: 41777, 41817, 41874, 42029, 42068, 42108, 42409, 42410, 42525, 42687, 42688, 42689, 42691, 42692, 42693, 42699, 42700, 42701, 42986, 42987, 42988, 42989, 43186, 43187, 43188, 43408, 581766, 581767, 583285, 583286
  • Manufacturing dates: March, 2015 to February, 2016
  • Distribution dates: April 20, 2015 to February 19, 2016
  • Devices recalled in the U.S.: 5,283 units in Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia
Picture of Guardian II Hemostasis Valve

Photo of Guardian II Hemostasis Valve

Device Use:

The Guardian II Hemostasis Valve is intended to reduce blood loss during cardiac catheterization procedures.

Reason for Recall:

Vascular Solutions is recalling the Guardian II Hemostasis Valve because of a defect in the low pressure seal, which may allow air bubbles into the device and block blood supply to the heart or blood vessels (air embolism).

The use of affected products may cause serious adverse health consequences, including death.

Who May be Affected:

  • Patient groups undergoing hemostasis therapy using this device
  • Health care professionals using this device for diagnostic or interventional catheterization procedures

What to Do:

On March 3, 2016, Vascular Solutions sent an Urgent: Medical Device Recall letter to customers asking them to:

  • identify the location of all affected products in their possession
  • remove and secure all affected products from their inventory
  • complete the inventory form enclosed with the letter and return it to Vascular Solutions’ customer service department by email at customerservice@vasc.com or by fax at 763-656-4251

Date Recall Initiated:

March 4, 2016

Additional Resources:

FDA MedWatch Safety Alert for this Recall

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

 

 

 

Page Last Updated: 04/15/2016
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