On June 21, 2017, Vascular Solutions Inc. recalled the Venture catheter due to the risk that the catheter tip will split or separate during use. Excess material at the tip of the catheter may separate and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.
The Venture catheter is intended for directing, steering, controlling, and supporting a guidewire to access veins and arteries in the arms, legs, hands, feet, and heart muscle (myocardium). Certain models may also administer saline fluids or drugs into blood vessels.
The recall included all lots of the Venture Rapid Exchange (RX) Catheter (Model 5820), Venture Over-the-Wire (OTW) Catheter (Model 5821), and Venture Coronary Sinus (CS) Catheter (Model 5822). Recalled catheters were distributed between May 7, 2015, and April 19, 2017. Recalled catheters were manufactured between May 7, 2015, and March 31, 2017. Approximately 7,054 devices were recalled in the U.S.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood – The Liability Risks