Vascular Solutions Twin-Pass .023" Dual Access Catheter… recallZ-0055-2017 · Vascular Solutions, Inc. · initiated Sep 16, 2016
Class I Terminated All recalls posted in October 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vascular Solutions, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0055-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Sep 16, 2016
- Posted by the FDA
- Oct 20, 2016
- Recalling firm
- Vascular Solutions, Inc.
- Quantity
- 11,670 units total
- Product code
- DQO
- FDA submissions
- K062877
- 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.
Product description
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 (models, lots, serial numbers)
Model 5230, Lot numbers: 577279, 578997, 580613, 583021, 584463, 586310, 588542, 590739, 591262, 593696, 593985.
Other devices under the same FDA submission
1 device cleared under K062877 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Twin-Pass® 023" dual access catheter 5230Vascular Solutions, Inc. · Catheter, Intravascular, Diagnostic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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