The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0053-2017·Announced 2016-10-26

Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material

Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."

Plain-English summary

Vascular Solutions, Inc. is recalling the Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. These are dual lumen catheters designed for use in the coronary and/or peripheral vasculature. The recall involves 11,670 units distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.

The recall is being conducted 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. The source text does not specify reported injuries or illnesses associated with this defect.

Healthcare providers and facilities should check their inventory for the affected models and lot numbers listed in the official recall notice. Users should stop using the affected devices and contact Vascular Solutions for further instructions.

The recalled product

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…
Manufacturer
Vascular Solutions, Inc.
Category
Medical Device — Catheter
Hazard
Affected units
11,670

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model 5200
  • Lot numbers: 575653
  • 577278
  • 577761
  • 578419
  • 578996
  • 579472
  • 579787
  • 580186
  • 580612
  • 581252
  • 582138
  • 582579
  • 582580
  • 583785
  • 584155
  • 584156
  • 584812
  • 585176
  • 585784

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Vascular Solutions, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Vascular Solutions, Inc.

See all →

Same hazard · foreign object

See all →

Similar recalls