The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning two Implantable Left Ventricular Assist Devices (LVADs). The affected devices are as follow:-
FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec's HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. FDA is also aware of bleeding complications related to both the Thoratec HeartMate II and HeartWare HVAD.
When used for the currently approved indications in appropriately selected patients, FDA believes the benefits of these LVADs continue to outweigh the risks. However, the FDA also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457333.htm
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm457327.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 August 2015