The U.S. Food and Drug Administration (FDA) just announced a Class I recall of Vascular Solutions Inc.’s Guardian II and Guardian II NC Hemostasis Valves.
Vascular Solutions initiated the recall due to the risk that air might be introduced into the device, which could lead to an air embolism. The Class I designation, the agency’s most serious, indicates that the recall involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The model numbers involved in the Vascular Solutions’ recall of the Guardian II and Guardian II NC Hemostasis Valves are: 8210, 8211, 8215, and 8216. The recalled devices were manufactured and distributed from February 2012 to February 2013. A list of the recalled lot numbers is also available from Vascular Solutions and has been provided to each facility that purchased the affected products.
The Guardian II and Guardian II NC hemostasis valves, manufactured by Vascular Solutions, are intended to reduce blood loss during catheterization procedures.
Vascular Solutions sent an “Urgent Medical Device Recall” letter to its customers on February 28, 2013. The letter described the problem and the hemostatis valves involved in the recall. Vascular Solutions advised its customers to immediately remove the recalled product from their inventory and secure the Guardian II and Guardian II NC Hemostasis Valves.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting a report online at www.fda.gov/MedWatch/report.htm or by calling the agency, toll-free, at 1.800.332.1088 to request a reporting form.