| Class 1 Device Recall TwinPass Dual Access Catheter | |
Date Initiated by Firm | September 16, 2016 |
Date Posted | October 20, 2016 |
Recall Status1 |
Terminated 3 on May 04, 2018 |
Recall Number | Z-0055-2017 |
Recall Event ID |
75243 |
510(K)Number | K062877 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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Product | Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 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 5230, Lot numbers: 577279, 578997, 580613, 583021, 584463, 586310, 588542, 590739, 591262, 593696, 593985. |
Recalling Firm/ Manufacturer |
Vascular Solutions, Inc. 6464 Sycamore Ct N Maple Grove MN 55369-6032
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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 2 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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