Vascular Solutions Recalls More Catheters for Safety Concerns

Patrice Wendling

June 21, 2017

MINNEAPOLIS, MN — The Venture catheter (Vascular Solutions) is being recalled because of a risk for excess material at the tip of the catheter to separate during use and enter the patient's bloodstream, according to the manufacturer[1].

Release of the material "can result in serious adverse health consequences such as development of blood clots, embolism of the excess material to vital organs, or death," the recall notice, posted June 21, 2017 with the US Food and Drug Administration, states.

The Venture catheter is used during vascular procedures to control and support a guidewire used to access veins and arteries in the myocardium, arms, legs, hands, and feet. Certain models are also used to administer saline fluids or drugs into blood vessels.

In October 2016, as reported by theheart.org|Medscape Cardiology, Vascular Solutions issued a nationwide recall for its Twin-Pass Dual Access catheters for similar safety concerns.

The present recall affects 7054 Venture catheters distributed in the US from May 7, 2015 to April 19, 2017 and includes the Venture RX Catheter (model 5820), Venture OTW (model 5821), and Venture CS Catheter (model 5822). A list of affected lot numbers can be found here.

Vascular Solutions advised distributors and customers in an April 25, 2017 medical device recall letter to remove any affected Venture catheters from inventory and quarantine and to ensure that all customers who received the catheters are notified.

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