Agency classClass IOur severity:Severe FDA (Devices)·Z-1747-2020·Announced 2020-05-06

Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

Vascular Solutions is recalling 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 30,877 units of the Langston Dual Lumen Catheter 6F Model 5540. This medical device is used for the delivery of contrast medium in angiographic studies.

The recall was initiated because the inner lumen of the catheter may separate from the hub during pressure injection. The affected units were distributed worldwide, including in the United States, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.

The recalled product

Product: Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Manufacturer: Vascular Solutions, Inc.
Category: Medical Device — Catheter
Hazard: structural-defect
Affected units: 30,877

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)

Model 5540
UDI 10841156100513
Lots 651278
651457
651920
652097
652176
652459
652628
652777
653053
653319
653443
653565
653776
653863
654010
654190
654340
654514

Distribution

Distributed nationwide across the United States.

Same manufacturer · Vascular Solutions, Inc.

See all →

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Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
Severe
Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
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Severe
Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
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Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
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Same hazard · structural defect