Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
Vascular Solutions, Inc. is recalling 2,990 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 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: "The inner lumen of the Langston catheter may separate from the hub during pressure injection."
Plain-English summary
Vascular Solutions, Inc. is recalling 2,990 units of the Langston Dual Lumen Catheter. The recall involves Model Number 5550 and specific lot numbers including 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, and 666755.
The recall is being conducted 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 for medical procedures.
The affected devices were distributed domestically across the United States and internationally to countries including 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 the United Kingdom. Healthcare facilities and distributors should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Langston Dual Lumen Catheter.
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 2,990
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 (18)
- Model Number: 5550
- UDI 10841156100537 total 2990
- Lots: 637973
- 640204
- 659555
- 660597
- 633668
- 663767
- 669593
- 659856
- 644096
- 676528
- 672481
- 632704
- 656792
- 658273
- 666755
- 635885.
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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