Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall. Medtronic began notifying … [Read more...]
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Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts
DUBLIN - April 6, 2017 - Medtronic plc (NYSE: MDT) today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic's Neurosurgery business, which is part of the Brain Therapies division of the … [Read more...]
Medtronic Announces Worldwide Voluntary Field Corrective Action for Newport™ HT70 and Newport™ HT70 Plus Ventilators
Medtronic (NYSE: MDT) is notifying customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying … [Read more...]
Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters
This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. … [Read more...]
Medtronic Announces Worldwide Voluntary Recall for Battery Pack In Covidien Oridion Labeled Capnostream™20 and Capnostream™20p Patient Monitors
DUBLIN – Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream™20 and Capnostream™20p Patient Monitors. This voluntary recall is being conducted due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. … [Read more...]
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