Home / Recalls / Vascular Solutions, Inc. / Z-1981-2014

Z-1981-2014 Class I Terminated

Recalled by Vascular Solutions, Inc. — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
July 9, 2014
Initiation Date
May 27, 2014
Termination Date
January 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,580 total (US 5714)

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.

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.

Distribution Pattern

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

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.

Other recalls by Vascular Solutions, Inc.

  • Z-0112-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0110-2021 Class I — Langston Dual Lumen Catheter (August 31, 2020)
  • Z-0111-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0113-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-1747-2020 Class I — Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in (March 16, 2020)
  • Z-2249-2018 Class II — Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (May 4, 2018)
  • Z-2224-2017 Class I — Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Ca (April 25, 2017)
  • Z-2180-2017 Class II — Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. (April 12, 2017)
  • Z-1250-2017 Class II — GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Pr (January 12, 2017)
  • Z-0053-2017 Class I — Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. (September 16, 2016)