Vascular Solutions, Inc. Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Brand
Vascular Solutions, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Vascular Solutions, Inc. is recalling Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies due to The inner lumen of the Langston catheter may separate from the hub during pressure injection.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Recommended Action
Per FDA guidance
The firm notified consignees that received affected product on March 26, 2020 via UPS Mail (US), email or mail (OUS). The firm s immediate correction is to recall the affected devices for destruction. The notice includes instructions on subrecall for any consignees that further distributed affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026