Stryker Sustainability Solutions voluntarily recalled 167 of its Angiodynamics Soft Vu Omni Flush angiographic catheters.
The company received reports of the tip of the catheter separating from the main body, which could lead to loss of device function, surgical intervention or other complications. The tip separation can also cause organ injury, stroke, kidney failure, intestinal failure and death in some circumstances, according to an FDA release on July 22.
Healthcare professionals use the catheters to inject dye into the blood vessels to prepare for a cardiac angiogram. They insert the catheters through a small skin puncture and into a blood vessel.
The recalled products were manufactured from Nov. 7, 2003, to Oct. 18, 2008, and distributed from Jan. 5, 2004, to Dec. 3, 2008.
Stryker recalled devices in Texas, Utah, Pennsylvania, California, Vermont, Maine, Washington, Virginia, New York, Maryland and Connecticut.