June 22, 2017

FDA: Vascular Solutions recalls Venture Catheters

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on June 21 announced the recall by Vascular Solutions (Maple Grove, Minnesota) of its Venture Catheters.

The recall was initiated because there is a risk of the catheter tip splitting or separating during use and entering the patient’s bloodstream. This can result in serious adverse effects such as blood clots, embolism to vital organs, or death.

The catheters are used to direct, steer, control, and support a guidewire to access veins and arteries in the arms, legs, hands, feet, and heart.

The catheters were distributed between May 7, 2015, and April 19, 2017.

Posted 06/21/2017] AUDIENCE: Risk Manager, Cardiology ISSUE: Vascular Solutions Inc. is recalling the Venture catheter because there is a risk of the catheter tip splitting or separating during use. Excess material at the tip of the catheter may separate and could enter the patient's bloodstream.

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