Thoratec Recalls Implantable Ventricular Assist Devices

Thoratec has issued a Class I recall of its Implantable Ventricular Assist Devices (IVADs) with serial numbers 488 and higher that were manufactured and distributed from Oct. 1, 2004, through Oct. 22, 2007.

The instructions for use state that IVADs may be implanted in the pre-peritoneal position or placed in the paracorporeal position, the company said. However, in the paracorporeal position, the pneumatic driveline is external to the patient and may be damaged if the driveline is bent at a sharp angle relative to its junction with the pump housing, which could cause a reduction or interruption of circulatory support.

The affected IVADs were distributed to 87 hospitals throughout the U.S. and other countries, according to Thoratec. The company has received seven reports of damaged drivelines in paracorporeal IVADs, five of which resulted in patient injuries and one in a patient death.