Early last month, Guardian® II hemostasis valves recalled by Vascular Solutions, Inc. The valves are used in catheterization procedures to stop the flow of blood and certain of the valves have a defect that could cause serious injury or death.
Early last month, Guardian® II hemostasis valves recalled by Vascular Solutions, Inc. The valves are used in catheterization procedures to stop the flow of blood and certain of the valves have a defect that could cause serious injury or death. This voluntary recall is a result of Vascular Solutions learning that certain of the hemostasis valves might allow excess air leakage, which could result in an air embolism (bubble in a vein or artery). Air embolism is a dangerous condition.
To date, no injuries have been reported.
The recalled valves are from certain lots of Model Numbers 8210 and 8211.
These hemostasis valves were made between March 2015 and February 2016. Distribution to healthcare facilities took place from April 2015 to February 2016.
It’s important to note that this recall is for the Guardian II hemostasis valves only and not the Guardian II NC hemostasis valves.
The recalled lot numbers have been given to all healthcare facilities that purchased the valves along with instructions to remove the valves from inventory and return them to the manufacturer. The list of recalled valves is available from Vascular Solutions. A small number (2.4%) of the total valves manufactured during the affected time period are defective. Of 26,550 total Guardian II hemostasis valves, 5,283 were sold in the U.S.
On March 3, the manufacturer voluntarily issued Urgent Medical Device Recall notices to all healthcare facilities that bought the affected lots. The notice included means of identifying the lots and how to return them to Vascular Solutions.
The FDA was also notified. The agency has classified this recall as Class I. This is a high-danger classification that the agency uses for “situation[s] 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.”
If you have questions regarding this recall, please contact Vascular Solutions, Inc. at:
- 1-888-240-6001 Monday – Friday, 8AM – 5PM Central Time, or
Quality problems and adverse reactions related to these valves should be reported to the FDA’s MedWatch Adverse Event Reporting program:
- Online at http://www.fda.gov/medwatch/report.htm which provides a form you can fax to 1-800-FDA-0178, or
- Call the FDA at 1-800-FDA-1088 to request a reporting form