Vascular Solutions, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0053-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: September 16, 2016

Date Posted: October 26, 2016

Recall Number: Z-0053-2017

Event ID: 75243

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.

Status: Terminated

Product Quantity: 11,670 units total

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated