Z-1747-2020Class I

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

Name: Z-1747-2020 Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Creator: Vascular Solutions, Inc.
Published: 2020-03-16
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2020-03-16 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies on 2020-03-16. FDA classified it as Class I and gives the reason as "The inner lumen of the Langston catheter may separate from the hub during pressure injection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1747-2020
Classification: Class I
Status: Terminated
Initiated: 2020-03-16
Posted: 2020-04-27
Terminated: 2024-06-18
Recalling firm: Vascular Solutions LLC
Product: Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1747-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1747-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-27

Product code DQO

K051395Class IILangston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. / cleared 2005-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)