Z-0054-2017Class I

Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The...

Name: Z-0054-2017 Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The...
Creator: Vascular Solutions, Inc.
Published: 2016-09-16
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2016-09-16 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter... on 2016-09-16. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0054-2017
Classification: Class I
Status: Terminated
Initiated: 2016-09-16
Posted: 2016-10-20
Terminated: 2018-05-04
Recalling firm: Vascular Solutions LLC
Product: Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. 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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 11,670 units total
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 codes and lots: Model 5210, Lot number: 577762

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0054-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0053-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0054-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0055-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20

Product code DQY

K060327Class IIVascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. / cleared 2006-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)