FDA Medical Device Recalls (openFDA)
Vascular Solutions, Inc.: Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Recall number
- Z-1747-2020
- Recalling firm
- Vascular Solutions, Inc.
- Product
- Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Status
- Terminated
- Initiated
- 2020-03-16
- Posted
- 2020-04-27
- Terminated
- 2024-06-18
- Reason
- The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 30,877 units
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K051395"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 3002827704
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28