Venture Catheter Recall [US]

US FlagUS/Silver Spring: Logo - Venture CathetersVascular Solutions, Inc. recalls all batch/lots worldwide of Venture Catheters due to suspected extraneous material in the inner lumen of the distal Catheter tip and consequential component detachment or extrusion during use, embolism, serious injury and/or death hazards. FDA: http://ht.ly/Dkzn30d8YmD

Direct link: https://www.fda.gov/Safety/Recalls/ucm564419.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Catheters are subject to this recall (in alphanumeric order):

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Guardian II Hemostasis Valve Recall [US]

US Flag

US/Silver Spring: FDA Logo BlueVascular Solutions, Inc. recalls certain batch/lots of Guardian II Hemostasis Valves due to increased risk of air leakage that may lead to an air embolism, injury and death, all serious health hazards. FDA: http://ht.ly/10xYxQ

Direct link: http://www.fda.gov/Safety/Recalls/ucm495295.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Medical Devices are subject to this recall:

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