Medtronic HeartWare Recall Given Most Serious Designation By FDA
The FDA says problems with Medtronic Heartware HVAD implants, which resulted in its removal from the market, put patients at risk of severe injury or death.
Search Results For: heartware
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HeartWare Heart Pump Problems Were Known, But Dangerous Implants Continued: Report
A new report indicates the FDA and Medtronic knew of HeartWare implant problems and deaths for years, but took little action to make the devices safer and kept allowing them…
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Medtronic HeartWare HVAD Removed From The Market Following Recalls, Injuries and Deaths
After issuing a series of Class I recalls for HeartWare HVAD systems over the past decade, Medtronic has announced that it will remove the cardiac devices from the market, as…
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Medtronic HeartWare HVAD Instruction Recall Issued Over Safety Concerns
Another Medtronic HeartWare HVAD recall has been issued, this time to clarify instructions which, if misinterpreted, could lead to serious injuries and deaths.
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Medtronic Heartware HVAD Cable Recall Latest Of Heart Device’s Woes
The latest in a series of Medtronic HeartWare HVAD recalls in recent years comes after at least 12 deaths and hundreds of complaints of problems with battery cables and data…
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Medtronic HeartWare HVAD Recall: Defective Screw Placing Patients At Risk Of Injury, Death
A Medtronic HeartWare HVAD implant recall warns that a defective screw could result in delay in treatment, bleeding injuries, and death.
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Medtronic HeartWare HVAD Recall Issued Due to Power Failure Risk
Federal regulators have announced a class I recall for the Medtronic HeartWare HVAD cardiac device, indicating that it may stop working, posing a risk of serious injury or death for…
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Recalled HeartWare Heart Implants Pose Risk of Serious Injury, Death, FDA Warns
Two recent HeartWare Ventricular Assist Device recalls have been given Class I designations by the FDA, meaning they carry a serious risk of severe injury or death.
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Heartware Ventricular Assist Device Recall Issued Due to Loose Connector Risk
Another HVAD recall has been announced, this time involving heart pump controllers that may have loose connections.
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Heartware Ventricular Assist Device Recall: Electrical Problems That Could Cause Death
A risk of malfunctions that could cause serious injury or death has led to the recall of some Heartware Ventricular Assist Device heart pumps.