Vascular Solutions, Inc. recalls Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using et…

Recall date

April 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2224-2017

FDA classification

Class I

Brand / firm

Vascular Solutions, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide): including states of: AK, AL, AR, AZ, CA, CO, CT, DC,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, ME, MI, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: AUSTRALIA, AUST…

Why it was recalled

Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents