Reported Jun 28, 2017 · Terminated
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using…
Vascular Solutions, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vascular Solutions, Inc. · 6464 Sycamore Ct N · Maple Grove, MN · 55369-6032
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
5820 | Venture RX Catheter |
5821 | Venture OTW Catheter |
5822. | Venture CS Catheter, 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 |
- Lot codes and dates
73 of 73 codes
581713582455582588583022583409583410584469584470599777584471585180585458585459585787586408586972587035587036587408587775588097588098588099588100588794589268589754589885589886590172590404590562590776591196591197591198592080592081592526592924593080593519593520593720594204594421595195595196595418595419596020597293597294597771597905597967598903599045599466599650
- Amount recalled
- 13,551 (7,054 are unexpired)
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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