MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use
Including Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS Catheter (Model 5822)
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. 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.
BACKGROUND: 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.
RECOMMENDATION: On April 25, 2017, Vascular Solutions Inc. sent an Urgent Medical Device Recall letter to all affected customers. The letter asked distributors and customers to:
Health care professionals and consumers may contact Vascular Solutions at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@xxxxxxxx with any questions related to this recall.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the FDA recall notice, at: