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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
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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