Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner catheter may separate from the hub during use, potentially requiring intervention to prevent injury.
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 catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury."
Plain-English summary
Vascular Solutions, Inc. is recalling Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. These devices are used as pressure measurement catheters and for the delivery of contrast media during angiographic studies. The recall involves 8,580 total units, with 5,714 units distributed in the United States. The remaining units were distributed worldwide, including in Austria, Canada, Germany, Israel, Italy, the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
The recall is being conducted because the inner catheter of some Langston V2 Dual Lumen Catheters has separated from the device hub during contrast pressure injections. This separation may require a medical intervention to retrieve the separated piece from the patient to prevent injury.
Healthcare facilities and distributors should stop using the affected devices and contact Vascular Solutions, Inc. for further instructions on retrieval or replacement. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheters
- Hazard
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)
- Lot Numbers: 569436
- 569437
- 569962
- 569963
- 569964
- 569965
- 570177
- 570178
- 570337
- 570338
- 570339
- 570340
- 570341
- 570504
- 570505
- 570506
- 570507
- 570592
- 570593
- 570674
Distribution
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