Ventricular Assist Devices
An Implantable Ventricular Assist Device (IVAD) is a mechanical pump that helps a weakened heart pump blood throughout the body. There are different kinds of IVAD’s, all of which are designed to provide sufficient blood flow to a damaged or diseased heart. It is sometimes referred to as a “bridge to transplant” since these devices are commonly used to help a patient survive until a heart transplant can be performed.
On October 19, 2007, Thoratec Corporation, the manufacturer of a popular IVAD, sent an Urgent Medical Device Correction notice to all of its customers notifying them of problems with their devices, specifically Catalog Number 10012-2555-001, serial numbers 488 or higher (manufactured and distributed from October 1, 2004 through October 22, 2007). The FDA is now assisting Thoratec with informing healthcare professionals of the Class I recall.
Class I recalls are the most serious type of recall, due to the fact they involve situations in which there is reasonable probability that the use of the product can cause serious injury and in some cases, even death.
To date, Thoratec has received seven reports of damaged drivelines in IVADs, five of which resulted in patient injuries and one in a patient death. The devices in question were distributed directly to 87 hospitals throughout the and other countries.
Read the Press Release from Thoratec Corporation.
The Thoratec Ventircular Assist Device System has been FDA approved for left, right and biventrical support for bridge-to-heart transplantation and for post-cardiotomy recovery. The devices manufacturer estimates that more than 4,300 of the devices have been used in treatment of over 2,800 patients worldwide.
IVADs are not intended to replace the heart. These devices are designed to assist the heart pump blood, therefore decreasing the workload of the left or right ventricle. During surgery, the doctor attaches the IVAD to the apex of the ventricle and to the aorta. Once the surgery has been completed and the ventricle starts to contract, blood will flow into the IVAD pump. When the heart relaxes, the ventricle then fills with blood, and the blood that previously entered the device is pumped into the aorta.
If you or a loved one have been injured by an Implantable Ventricular Assist Device, please call us at (800) 966-4999 or fill out our online contact form for a free case evaluation.
