FDA Video: Recall of Thoratec Implantable Ventricular Assist Devices

Below is an excellent video published by the U.S. Food & Drug Administration (FDA), which announces the recall of IVADs and warns of air leaks, injuries and deaths among patients.

The Thoratec Corporation is recalling some of its implantable ventricular assist devices (IVADs) because air leaks could develop in the driveline when the device is used outside the patient’s body. Five injuries and one death have been reported as a result of this problem.

These IVADs were designed to be implanted in the body. However, they have sometimes been used externally when certain patient characteristics prevent implantation. In the external position, damage can occur to the pneumatic driveline if it is bent at a sharp angle where the driveline meets the pump housing. One patient died when the driveline severed at its connection to the pump.

The recalled devices, which were distributed to 87 hospitals in the U.S. and abroad, have serial numbers 488 or higher. The serial numbers can be found on the sterile package and on the Y-connector at the end of the percutaneous driveline.

Thoratec is recommending that these IVADs not be placed in the external position. Patients who already have them in this position should be instructed to contact their doctors immediately. Additional information can be obtained from the company by calling 1-800-528-2577. Note that the recall does not affect IVADs that are implanted within the patient’s body.

Do I have a Thoratec Recall Lawsuit?

The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in medical device recall lawsuits. We are currently investigating the possibility of handling individual Thoratec recall litigation nationwide and currently accepting new Thoratec recall claims.

If you or a loved one have been adversely affected by the Thoratec recall and/or experienced cardiac device malfunctions, failure or injury, you should contact us immediately. You may be entitled to compensation by filing a Thoratec recall lawsuit and we can help.