by
Christina Hwang, Contributing Reporter | July 26, 2016
Labeled as Class I recall, the catheters
should be returned to manufacturer
Stryker recently announced a Class I recall of its Soft-Vu Omni Flush Angiographic Catheter.
The catheter, used to inject contrast dye into blood vessels to prepare a patient for a cardiac angiogram, is inserted into the body through a small puncture and into a blood vessel, and the company received reports of the tip of the catheter separating from the device.
“Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs,” the FDA said in its notice.
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“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,” it said.
On June 1, Stryker had sent out a Customer Notification letter telling its customers that there was a very likely chance of the tip separating from the body. The letter told its customers to stop using the affected recalled products, check their facility for unused affected products, and to ship everything back to them.
The recall affects the catheters manufactured between November 7, 2003 and October 18, 2008 and delivered between January 5, 2004 and December 3, 2008.
