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Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Ox...

FDA Device Recall #Z-0055-2017 — Class I — September 16, 2016

Recall Summary

Recall Number Z-0055-2017
Classification Class I — Serious risk
Date Initiated September 16, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vascular Solutions, Inc.
Location Maple Grove, MN
Product Type Devices
Quantity 11,670 units total

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.

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.

Distribution Pattern

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.

Lot / Code Information

Model 5230, Lot numbers: 577279, 578997, 580613, 583021, 584463, 586310, 588542, 590739, 591262, 593696, 593985.

Other Recalls from Vascular Solutions, Inc.

Recall # Classification Product Date
Z-0113-2021 Class I Langston Dual Lumen Catheter. Aug 31, 2020
Z-0110-2021 Class I Langston Dual Lumen Catheter Aug 31, 2020
Z-0112-2021 Class I Langston Dual Lumen Catheter. Aug 31, 2020
Z-0111-2021 Class I Langston Dual Lumen Catheter. Aug 31, 2020
Z-1747-2020 Class I Langston Dual Lumen Catheter 6F Model 5540. Fo... Mar 16, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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