Class 1 Device Recall TwinPass Dual Access Catheter

• Date Initiated by Firm: September 16, 2016
• Date Posted: October 20, 2016
• Recall Status: Terminated on May 04, 2018
• Recall Number: Z-0053-2017
• Recall Event ID: 75243
• 510(K)Number: K052257
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
• Code Information: Model 5200, Lot numbers: 575653, 577278, 577761, 578419, 578996, 579472, 579787, 580186, 580612, 581252, 582138, 582579, 582580, 583785, 584155, 584156, 584812, 585176, 585784, 585785, 586399, 587030, 587407, 587772, 588499, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 591037, 591261, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593717, 594199, 594419, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037.
• Recalling Firm/ Manufacturer: Vascular Solutions, Inc.; 6464 Sycamore Ct N; Maple Grove MN 55369-6032
• For Additional Information Contact: Customer Service; 763-656-4300
• Manufacturer Reason for Recall: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
• FDA Determined Cause: Process control
• Action: Vascular Solutions sent an Urgent Medical Device Recall letter via first class mail beginning 9/16/2016. The letter identified affected product, stated the issue, and instructed that product should not be used and to be returned to Vascular Solutions. A response form was requested to be returned. Questions can be directed to Customer service by e-mail at customerservice@vasc.com.
• Quantity in Commerce: 11,670 units total
• Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
• 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