Medical DeviceOct 28, 2020
Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0111-2021
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Recall history in this database
Classification mix: Class I: 12, Class II: 5.
Medical DeviceOct 28, 2020
Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0110-2021
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceOct 28, 2020
Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0113-2021
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceOct 28, 2020
Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0112-2021
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceMay 6, 2020
Vascular Solutions Langston Dual Lumen Catheter 6F Model 5540 recall — FDA Z-1747-2020
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceJun 27, 2018
Vascular Solutions Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x recall — FDA Z-2249-2018
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.
Class IIFDA: TerminatedVascular Solutions, Inc.
Medical DeviceJun 28, 2017
Vascular Solutions Venture RX Catheter, Model 5820 recall — FDA Z-2224-2017
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…
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceJun 7, 2017
Vascular Solutions Dolphin Inflation Device, REF 0185NA recall — FDA Z-2180-2017
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…
Class IIFDA: TerminatedVascular Solutions, Inc.
Medical DeviceMar 1, 2017
Vascular Solutions GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide recall — FDA Z-1250-2017
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Class IIFDA: TerminatedVascular Solutions, Inc.
Medical DeviceOct 26, 2016
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230 recall — FDA Z-0055-2017
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…
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceOct 26, 2016
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210 recall — FDA Z-0054-2017
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…
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceOct 26, 2016
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230 recall — FDA Z-0053-2017
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…
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceApr 13, 2016
Vascular Solutions Guardian II Hemostasis Valve, models 8210 and 8211 recall — FDA Z-1275-2016
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…
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceJul 9, 2014
Vascular Solutions Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540 recall — FDA Z-1981-2014
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…
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceMar 27, 2013
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in recall — FDA Z-0955-2013
Risk that air may be introduced into the device which may lead to an air embolism.
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceFeb 27, 2013
Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only recall — FDA Z-0868-2013
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…
Class IIFDA: TerminatedVascular Solutions, Inc.
Medical DeviceSep 26, 2012
Vascular Solutions Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis recall — FDA Z-2400-2012
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…
Class IIFDA: TerminatedVascular Solutions, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Vascular Solutions, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.