Vascular Solutions, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1981-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: May 27, 2014

Date Posted: July 9, 2014

Recall Number: Z-1981-2014

Event ID: 68489

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.

Status: Terminated

Product Quantity: 8,580 total (US 5714)

Code Information:

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.

Distribution Pattern:

Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.

Voluntary or Mandated:

Voluntary: Firm initiated