FDA Device recall Z-1981-2014
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540
- FDA Device
- Class I
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class I recall of Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540 by Vascular Solutions, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1981-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-27 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vascular Solutions |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Numbers: 569436, 569437, 569962, , 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 5703…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, and 571727. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1981-2014%22
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