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

Class I FDA enforcement event 85350. Recall start date: 16 Mar 2020. Status in the FDA record: Terminated. Termination date: 18 Jun 2024.

Reason for recall, in the words of FDA

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Vascular Solutions, Inc. started this device recall on 16 Mar 2020. The firm address in the FDA record is in Maple Grove, MN. FDA put the recall in Class I. FDA event 85350 has 1 product record. The first FDA enforcement report date is 6 May 2020. The record gives the status Terminated, with the termination date 18 Jun 2024.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa,…

Recalling firm

Vascular Solutions, Inc., Maple Grove, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 85350: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1747-2020	Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies	30,877 units	Class I	Terminated	6 May 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class I: 4%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Vascular Solutions, Inc.
Initiated	Product (first record)	Type	Class	Records
31 Aug 2020	Langston Dual Lumen Catheter	Device	Class I	4
4 May 2018	Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer	Device	Class II	1
25 Apr 2017	Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using eth	Device	Class I	1
12 Apr 2017	Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflati	Device	Class II	1
12 Jan 2017	GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer ki	Device	Class II	1
16 Sep 2016	Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin	Device	Class I	3
4 Mar 2016	Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101	Device	Class I	1
27 May 2014	Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring ca	Device	Class I	1
27 Feb 2013	Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers	Device	Class I	1
29 Jan 2013	Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324,	Device	Class II	1

Vascular Solutions, Inc.: all 12 events

Official channels

FDA enforcement report Z-1747-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 85350. https://recallregister.com/fda/i/85350/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa,…
What quantity of product is in FDA event 85350?: The FDA record gives this quantity: 30,877 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 4% of the 916 device events that started in 2020 are in Class I.