Recall of Thoratec Implantable Ventricular Assist Devices

Posted on April 29, 2008

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.

Additional Information:

FDA MedWatch Safety Alert. Thoratec Implantable Ventricular Assist Devices. November 16, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#IVAD

URGENT Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device. November 8, 2007.
http://phx.corporate-ir.net/phoenix.zhtml?c=95989&p=irol-newsArticle&ID=1074762&highlight=

Class 1 Recall: Thoratec Corporation Implantable Ventricular Assist Devices (IVAD). November 16, 2007.
http://www.fda.gov/cdrh/recalls/recall-101907.html