FDA: Angiographic Catheter Recalled Due to Potential Tip Separation
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling some lots of the Angiodynamics Soft-Vu Omni Flush angiographic catheter after receiving reports of the tip separating from the main portion of the device.
The US Food and Drug Administration (FDA) has classified the recall as class I, meaning that use of the affected catheters may cause serious injuries or death.
In the recall notice, the agency says that separation could potentially obstruct blood flow and require survival intervention.
“Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure, among other serious adverse health consequences, including death,” the notice reads.
The company first alerted customers to the possible issue in a June 1 letter, instructing them to stop using the affected products and return any unused catheters.
The recall affects catheters manufactured between November 7, 2003, and October 18, 2008, and distributed between January 5, 2004, and December 3, 2008, in 11 states: California, Connecticut, Maine, Maryland, New York, Pennsylvania, Texas, Utah, Vermont, Virginia, and Washington. Specific lot numbers can be found in the recall notice.
US Food and Drug Administration. Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) recalls flush angiographic catheter due to tip separation. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm512633.htm. Published on: July 22, 2016. Accessed on: July 22, 2016.