Stryker Recalls Soft Vu Heart Catheters

July 25, 2016 — The FDA has issued a Class 1 recall for some heart catheters made by Stryker Solutions.

The recalled product is the Angiodynamics Soft Vu Omni Flush, which is a thin plastic tube that is inserted into an artery. It injects a special dye that helps doctors visualize blood vessels before a cardiac angiogram, a type of X-ray used to diagnose heart conditions.

Stryker has received reports of the tip of the catheter separating. If this occurs, the catheter may not work and surgery may be necessary to retrieve the separated tip.

The separated tip could also block blood-flow to vital organs. This could result in life-threatening complications. According to the FDA:

“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 recalled heart catheters were made from November 7, 2003 through October 18, 2008. Check the FDA recall notice for affected lot numbers.

Stryker initiated the recall on June 1 with a “Customer Notification” letter. The company recommends discontinuing use of the recalled products, checking inventories for recalled products, and shipping all recalled products back to Stryker.

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