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Recall Observatory FDA recall evidence

Device product

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

Z-1747-2020

March 16, 2020

Class I

Product summary

Firm
Vascular Solutions, Inc.
Event
Event 85350
Status
Terminated
Classification
Class I
Quantity
30,877 units
Official record key
device-enforcement:Z-1747-2020

Official wording

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

Code information: 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

Distribution pattern: Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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