The Recall Desk
SevereFDA (Devices)·Z-0110-2021·Announced 2020-10-28

Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation

Vascular Solutions, Inc. is recalling 1,680 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored as at least 4 (Severe).

Plain-English summary

Vascular Solutions, Inc. is recalling 1,680 units of the Langston Dual Lumen Catheter, Model Number 5515. The recall involves specific lot numbers including 635806, 640206, 644140, 648701, 654143, 658252, 659635, 661470, 665301, 670376, 654130, 672728, 656020, 638111, and 677058.

The recall was initiated because the inner lumen of the catheter may separate from the hub during pressure injection. This defect poses a risk to patients and healthcare providers using the device.

The affected products were distributed domestically across numerous U.S. states and territories, including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. International distribution included countries such as Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product
Langston Dual Lumen Catheter
Manufacturer
Vascular Solutions, Inc.
Category
Medical Device — Catheter
Hazard
Affected units
1,680

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 (16)

  • Model Number: 5515
  • UDI 10841156100506 Lot Numbers: 635806
  • 640206
  • 644140
  • 648701
  • 654143
  • 658252
  • 659635
  • 661470
  • 665301
  • 670376
  • 654130
  • 672728
  • 656020
  • 638111
  • 677058.

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Vascular Solutions, Inc.

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Same hazard · structural failure

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