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.
Tag Archives: HeartWare
-
-
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…
-
Failed Heart Devices Cost Medicare $1.5B: Health Dept. OIG Report
A new report indicates that Medicare spent $1.5 billion on failed and recalled heart implant replacements over a 10 year period, and called for more specific medical device identification on…
-
Medtronic HVAD Controller Recall Declared By FDA After Update To Address Safety Issues
A Class I recall has been announced regarding Medtronic HVAD controllers, which are being updated after problems that may have lead to the deaths of at least two patients.
-
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.
-
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.
-
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.
-
HeartMate II, HeartWare LVAD Devices Linked to Reports of Serious Problems , FDA Warns
The FDA is warning of serious adverse event risks tied to two heart implants, the HeartMate II and the Heartware HVAD, which could cause bleeding, strokes, and blood clot problems.
-
HeartWare Ventricular Assist System Recall: Bent Pins Could Lead To Death
HeartWare is recalling hundreds of ventricular assist systems because connector pins can become bent, creating a risk of serious injury or death for patients.
-
HeartWare VAD Problems May Have Caused Serious Injuries, Deaths: FDA
The FDA has issued a warning letter to HeartWare, which indicates that it failed to make sure that corrections to a problem with the HVAD controller, already linked to at…