U.S. Food and Drug Administration06.22.17
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
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.
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.
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:
Recalled Product
- Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS Catheter (Model 5822)
- Lot Numbers: See Full List
- Distribution Dates: May 7, 2015 to April 19, 2017
- Manufacturing Dates: May 7, 2015 to March 31, 2017
- Devices Recalled in the U.S.: 7054 nationwide
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.
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.
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:
- Identify and remove any affected Venture catheters from inventory and quarantine.
- Ensure all customers who received any affected Venture catheters receive the Field Safety Notice and complete the Customer Inventory Form.
- After all the affected catheters are returned, complete the Vascular Solutions Inc. Distributor Inventory Form, and return it via email to regops@vasc.com.
- Upon receipt of the Vascular Solutions Inc. Distributor Inventory Form, Vascular Solutions' Customer Service Department will provide a Return Authorization number and arrange for return of affected Venture catheters. A credit will be offered after affected devices have been returned.