Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall - Risk of Air Being Introduced Into Device
Model Numbers 8210, 8211, 8215, and 8216
AUDIENCE: Risk Manager, Cardiology
ISSUE: FDA notified healthcare professionals of a Class I recall of the Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves, Model Numbers 8210, 8211, 8215, and 8216. The firm is recalling the product due to a risk that air may be introduced into the device which may lead to an air embolism. This product may cause serious adverse health consequences, including death.
A list of the recalled lot numbers is available from Vascular Solutions and has been provided to each facility that purchased the affected products. The recalled products were manufactured and distributed from February 2012 to February 2013.
BACKGROUND: The Guardian II and Guardian II NC hemostasis valves are intended to reduce blood loss during catheterization procedures.
RECOMMENDATION: On Feb. 28, 2013, Vascular Solutions sent an "Urgent Medical Device Recall" letter to its customers. The letter described the problem and the product involved in the recall. The firm advised its customers to immediately remove the recalled product from their inventory and secure it.
Healthcare professionals and patients are encouraged 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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178