RecallRadar

FDA Device recall Z-1747-2020

Langston Dual Lumen Catheter 6F Model 5540

On 2020-05-06 the FDA classified a Class I recall of Langston Dual Lumen Catheter 6F Model 5540 by Vascular Solutions, citing the inner lumen of the Langston catheter may separate from the hub during pressure injection.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1747-2020
ClassificationClass I
Statusterminated
Initiated2020-03-16
Published2020-05-06
Last updated2026-09-13 11:55 UTC
CompanyVascular Solutions
DistributionUS

Product

Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

Reason

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Identifiers

code_info
Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 65…Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 653443, 653565, 653776, 653863, 654010, 654190, 654340, 654514, 654657, 654889, 654890, 655128, 655287, 655460, 655465, 655738, 655869, 656191, 656533, 656554, 656727, 656801, 657030, 657243, 657517, 657627, 657680, 657866, 658018, 658151, 658250, 658438, 658541, 658671, 658824, 658984, 659122, 659217, 659362, 659443, 659630, 659855, 660075, 660199, 660288, 660397, 660590, 660717, 660823, 660910, 661139, 661257, 661474, 662824

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1747-2020%22

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