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.

Class I - Dangerous

🏥 Medical Devices Recalled: September 16, 2016 Vascular Solutions Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Vascular Solutions, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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 Codes/Lot Numbers:

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.