Z-1981-2014Class I

Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure...

Name: Z-1981-2014 Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure...
Creator: Vascular Solutions, Inc.
Published: 2014-05-27
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2014-05-27 / Terminated / root cause: design

FDA source

Vascular Solutions, Inc. began a recall of Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure... on 2014-05-27. FDA classified it as Class I and gives the reason as "The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1981-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-27
Posted: 2014-07-03
Terminated: 2015-01-30
Recalling firm: Vascular Solutions LLC
Product: Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Root cause tag: design
FDA root cause: Component design/selection
Action: Vascular Solutions sent an Urgent Medical Device Removal letter dated May 23, 2014, to all affected consignees.The letter described the problem and the product affected by the recall. Advised consignees to remove affected devices and place them in a secure area. Requested consignees to fill and return the "VSI Account Inventory Form" to VSI's Customer Service Department by email [email protected] or fax 763-656-4251. VSI will replace all returned devices. Customers with questions were advised to contact their local Vascular Solutions Account Manager. For questions regarding this recall call 763-656-4300.
Quantity in commerce: 8,580 total (US 5714)
Distribution: Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
Product codes and lots: Lot Numbers: 569436, 569437, 569962 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1981-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1981-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-03

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)