FDAnews Device Daily Bulletin

Vascular Solutions Recalls Guardian II Hemostasis Valves

April 13, 2016

Vascular Solutions is recalling its Guardian II hemostasis valves because of a potential risk of air leakage that could cause an air embolism.

In a statement, the company says the Class 1 recall excludes Guardian II NC valves, and no injuries linked to the device have been reported.

The nationwide recall — affecting lots of model numbers 8210 and 8211 — involves 26,550 devices, with 5,283 distributed in the U.S., which were manufactured between March 2015 and February 2016 and distributed between April 2015 and February 2016.

The company initiated the recall March 3. — Anisa Jibrell