Thoratec Corporation, in association with the FDA has issued an urgent Class 1 recall of the Thoratec TLC-II Portable Ventricular Assist Device (VAD), Thoratec Paracorporeal Ventricular Assist System, (PVAD) and the Thoratec Implantable Ventricular Assist Device (IVAD).
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
If you or a loved one have been 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.
What is the problem?
October 19, 2007 Implantable Ventricular Assist Device Recall: In October 2007, Thoratec issued an urgent nationwide recall of its popular TImplantable Ventricular Assist Device or IVAD.
The IVAD was recalled because the current Instructions for Use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline. These air leaks are a result of sharp bending of the driveline at the connection to the pump. This could result in not enough blood flow to and from the heart.
June 2007 – TLC-II® Portable Ventricular Assist Device Recall: In June 2007, Thoratec issued an urgent nationwide recall of its popular TLC-II® Portable Ventricular Assist Device or VAD.
VAD support for the patient’s circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient. This results in inadequate blood flow to and from the heart.
March 2007 – Paracorporeal Ventricular Assist System Recall: In March 2007, Thoratec issued an urgent nationwide recall of its popular Paracorporeal Ventricular Assist System or PVAD.
The PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use. The blood is pumped from the VAD through the cannula into the patient. (The black collet is similar to how a washer works with a nut. It is called a black collet because the collet and matching nut are painted black for easy identification).
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.
Thoratec Recall List
- Thoratec® Implantable Ventricular Assist Devices (IVAD), Catalog Number 10012-2555-001, serial numbers 488 or higher and manufactured and distributed from October 1, 2004 through October 22, 2007.
- Thoratec® TLC-II® Portable Ventricular Assist Device (VAD) Driver, Catalog Number 20010-0000-032.
- Thoratec® Paracorporeal Ventricular Assist System, (PVAD) Model TLC-II®, Catalog No. 14086-2550-000, manufactured from January 1, 2004 through October 2, 2006, and with expiration dates of January, 2007 to October, 2009.
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.