FDA MedWatch - Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use

Including Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS Catheter (Model 5822)

AUDIENCE: Risk Manager, Cardiology

ISSUE: 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.

• See the Recall Notice for a list of affected lot numbers
• 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

BACKGROUND: 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.

RECOMMENDATION: 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@xxxxxxxx.
• 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.

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@xxxxxxxx with any questions related to this recall.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA recall notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm564109.htm

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