FDA deems Vascular Solutions recall of hemostasis valve Class I

Guardian II Hemostasis Valve--Courtesy of Vascular Solutions

More than 5,000 hemostasis valves have been recalled by Vascular Solutions under a recall that's been deemed Class I by the FDA. That classification means the recalled device is a serious health risk or potentially could cause death.

The recalled device is the Guardian II Hemostasis Valve, which is for use to reduce blood loss during cardiac catheterization procedures. The recall is due to a defect in the low-pressure seal that can allow air bubbles into the device, which can block the blood supply to the heart or blood vessels

The recall is for devices distributed in the U.S. from April 2015 through February 2016. The company made the disclosure on April 8, after initiating the recall on March 3.

Recalled devices were made from March 2015 to February 2016. A total of 26,550 devices were manufactured with 5,283 distributed in the U.S. The company estimates that the problem indicated in the recall affects roughly 2.4% of the recalled devices.

The recalled products are specific lots of model numbers 8210 and 8211. The Guardian II NC hemostasis valves aren't affected.

Vascular Solutions ($VASC) markets products for coronary and peripheral vascular procedures. It went public in 2000 with a $42 million IPO--it now has a market cap of about $625 million, putting it on the brink of breaking out of small cap territory.

- here is the company's recall disclosure
- and the FDA recall notice