FDA Device recall Z-0053-2017

Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 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 Dual Access Catheter, models 5200, 5210, and 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-0053-2017
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 Dual Access Catheter, models 5200, 5210, and 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 5200, Lot numbers: 575653, 577278, 577761, 578419, 578996, 579472, 579787, 580186, 580612, 581252, 582138, 582… Model 5200, Lot numbers: 575653, 577278, 577761, 578419, 578996, 579472, 579787, 580186, 580612, 581252, 582138, 582579, 582580, 583785, 584155, 584156, 584812, 585176, 585784, 585785, 586399, 587030, 587407, 587772, 588499, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 591037, 591261, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593717, 594199, 594419, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037.

code_info

Model 5200, Lot numbers: 575653, 577278, 577761, 578419, 578996, 579472, 579787, 580186, 580612, 581252, 582138, 582…

Model 5200, Lot numbers: 575653, 577278, 577761, 578419, 578996, 579472, 579787, 580186, 580612, 581252, 582138, 582579, 582580, 583785, 584155, 584156, 584812, 585176, 585784, 585785, 586399, 587030, 587407, 587772, 588499, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 591037, 591261, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593717, 594199, 594419, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037.

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-0053-2017%22

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