Recall Z-2224-2017— Vascular Solutions, Inc.
Class I · Terminated
Class I FDA medical device recall by Vascular Solutions, Inc., initiated 2017-04-25, terminated 2019-11-05. It names 3 FDA 510(k) clearances: K061843, K042910, K040922. Product: 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. Reason: 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..
- Recalling firm
- Vascular Solutions, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-04-25
- Terminated
- 2019-11-05
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K061843 — VENTURE WIRE CONTROL CATHETER, MODEL WCC
- K042910 — VENTURE WIRE CONTROL CATHETER, MODEL WCC
- K040922 — VENTURE WIRE CONTROL CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.