FDA: Class I recall of Stryker’s Angiodynamics Soft Vu Omni Flush Angiographic Catheters

Editor's Note

The Food and Drug Administration (FDA) on July 22 categorized the recall of Stryker Sustainability Solutions' (Tempe, Arizona) Angiodynamics Soft Vu Omni Flush Angiographic Catheters as Class I, the most serious.

The recall was issued because of reports of separation of the catheter tip from the main body. Tip separation can lead to loss of device function, surgical intervention to retrieve a separated segment, internal organ injury, and other serious adverse health consequences including death.

The recall includes product manufacturing dates, November 7, 2003 to October 18, 2008, and distribution dates January 5, 2004 to December 3, 2008.

Posted 07/22/2016] AUDIENCE: Radiology, Cardiology, Risk Manager ISSUE: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body.