July 25, 2016 — Stryker Solutions has issued a recall for heart catheters because the tip can separate and cause life-threatening complications.
The recall affects Angiodynamics Soft-Vu Omni Flush angiographic catheters.
Stryker has received reports of the tip of the catheter breaking off inside the patient’s body. If this occurs, the patient may need emergency surgery to retrieve the tip.
Tip separation could also block blood-flow to the heart or other vital organs. 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.”
Angiographic catheters are thin plastic tubes that are inserted into the heart through a small incision in the skin. They are used to inject a dye into blood vessels, which helps doctors diagnose heart conditions before a type of X-ray known as a cardiac angiogram.
The FDA classified the recall as “Class 1.” It is the most serious type of recall, reserved for devices with a good chance of causing severe injury or death.
Stryker initiated the recall with a letter to customers on July 1. The company is asking customers to check inventories and return the recalled products.
The recall involved 147 catheters that were made November 7, 2003 through October 18, 2008. Click here for lot numbers.
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