Langston Dual Lumen Catheters — Class I medical device recall Z-1981-2014
Terminated recall by Vascular Solutions, Inc., reported 2014-07-09, distributed nationwide. The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast
| Recall number | Z-1981-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2014-05-27 |
| Classified | 2014-07-03 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-01-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, DE, ES, GB, IL, IT, NL, SE |
| Lot numbers | 569436, 569437, 569962, 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, 571727 |
| Model numbers | 5540, 5550 |
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.