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U.S. Department of Health and Human Services

Class 1 Device Recall TwinPass Dual Access Catheter

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 Class 1 Device Recall TwinPass Dual Access Cathetersee related information
Date Initiated by FirmSeptember 16, 2016
Date PostedOctober 20, 2016
Recall Status1 Terminated 3 on May 04, 2018
Recall NumberZ-0054-2017
Recall Event ID 75243
510(K)NumberK060327 
Product Classification Catheter, percutaneous - Product Code DQY
ProductVascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. 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 5210, Lot number: 577762 
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
For Additional Information ContactCustomer 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 2		Process control
ActionVascular 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 Commerce11,670 units total
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQY
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