FDA Device recall Z-0055-2017
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230
- FDA Device
- Class I
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class I recall of Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230 by Vascular Solutions, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0055-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-09-16 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vascular Solutions |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Model 5230, Lot numbers: 577279, 578997, 580613, 583021, 584463, 586310, 588542, 590739, 591262, 593696, 593985. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0055-2017%22
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