Vascular Solutions, Inc. recalls Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual…

Recall date

September 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0055-2017

FDA classification

Class I

Brand / firm

Vascular Solutions, Inc.

Sold / distributed

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 Afr…

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.