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.
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 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
- 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
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
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