Vascular Solutions Inc. Recalls Venture Catheters due to Excess Material that May Split or Separate During Use

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

• Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS  Catheter (Model 5822)
• Lot Numbers: See Full List Below
• 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

Device Use

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.

Reason for Recall

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.

Who May be Affected

• Health care providers using this device during vascular procedures
• All patient groups undergoing procedures involving Venture catheters

What to Do

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.

Contact Information

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@vasc.com with any questions related to this recall.

Date Recall Initiated

April 25, 2017

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Full list of Product Codes and Lot Numbers