Class 2 Device Recall GuideLiner V2 Catheter

• Date Initiated by Firm: January 17, 2012
• Date Posted: May 24, 2012
• Recall Status: Terminated on July 19, 2012
• Recall Number: Z-1655-2012
• Recall Event ID: 61825
• 510(K)Number: K112082
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.
• Code Information: 555038
• Recalling Firm/ Manufacturer: Vascular Solutions, Inc.; 6464 Sycamore Ct N; Minneapolis MN 55369-6032
• For Additional Information Contact: 763-656-4300
• Manufacturer Reason for Recall: Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.
• FDA Determined Cause: Material/Component Contamination
• Action: Vascular Solutions sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product , immediately remove the product and place the product in a secure area. Additionally, customers were asked to complete and return a Field Action Customer Inventory Form to the Customer Service Department via fax at 763-656-4251 or e-mail at customerservice@vasc.com. Customers may contact their local sales representative for questions concerning this recall.
• Quantity in Commerce: 330
• Distribution: Nationwide Distribution including the states of AL, AZ, AR, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LAM ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, WV, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY