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Vascular Solutions Recalls
17 recalls on record · September 26, 2012 to October 28, 2020 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 28, 2020Medical DevicesFDA
Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter.
Hazard: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
October 28, 2020Medical DevicesFDA
Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter.
Hazard: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
October 28, 2020Medical DevicesFDA
Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter.
Hazard: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
October 28, 2020Medical DevicesFDA
Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter
Hazard: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
May 6, 2020Medical DevicesFDA
Vascular Solutions, Inc. recalls Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Hazard: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
June 27, 2018Medical DevicesFDA
Vascular Solutions, Inc. recalls Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The D
Hazard: The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
June 28, 2017Medical DevicesFDA
Vascular Solutions, Inc. recalls Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using et
Hazard: Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.
June 7, 2017Medical DevicesFDA
Vascular Solutions, Inc. recalls Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile i
Hazard: The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product could pose a risk of microbial contamination, leading to infection.
March 1, 2017Medical DevicesFDA
Vascular Solutions, Inc. recalls GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introduc
Hazard: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
October 26, 2016Medical DevicesFDA
Vascular Solutions, Inc. recalls Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass d
Hazard: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
October 26, 2016Medical DevicesFDA
Vascular Solutions, Inc. recalls Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual
Hazard: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
October 26, 2016Medical DevicesFDA
Vascular Solutions, Inc. recalls Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The
Hazard: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
April 13, 2016Medical DevicesFDA
Vascular Solutions, Inc. recalls Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH1
Hazard: Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
July 9, 2014Medical DevicesFDA
Vascular Solutions, Inc. recalls Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring ca
Hazard: 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.
March 27, 2013Medical DevicesFDA
Vascular Solutions, Inc. recalls Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model nu
Hazard: Risk that air may be introduced into the device which may lead to an air embolism.
February 27, 2013Medical DevicesFDA
Vascular Solutions, Inc. recalls Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324,
Hazard: Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
September 26, 2012Medical DevicesFDA
Vascular Solutions, Inc. recalls Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemos
Hazard: Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.