Guardian II Hemostasis Valves by Vascular Solutions, Inc: Recall - Risk of Air Leakage

AUDIENCE: Risk Manager, Surgery

ISSUE: Vascular Solutions, Inc. initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. The recalled products are specific lots of Model Numbers 8210 and 8211. The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.

The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves.

BACKGROUND: A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 26,550 devices have been manufactured, with 5,283 distributed in the United States. The condition that led to the recall may affect approximately 2.4% of recalled devices.

RECOMMENDATION: Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.

Vascular Solutions Inc. voluntarily initiated the recall on March 3, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific lots subject to the recall and included instructions on how to return the affected products.

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
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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm495409.htm