|URGENT Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device|
PLEASANTON, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Thoratec Corporation initiated a worldwide recall on October 19, 2007 involving all Implantable Ventricular Assist Devices (IVAD) having Catalogue No. 10012-2555-001, serial numbers 488 or higher and manufactured and distributed since October 2004. The current Instructions for Use state that IVADs may be implanted in the pre-peritoneal (internal) position or placed in the paracorporeal (external) position. In the paracorporeal position, the pneumatic driveline is entirely 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, potentially resulting in serious injury or death.
The affected IVADs were distributed directly to 87 hospitals throughout the United States and other countries. They can be identified by the serial number located both on the label of the sterile package and on the Y-connector at the end of the IVAD percutaneous driveline.
The firm voluntarily issued an Urgent Medical Device Correction notice with new instructions regarding placement and care of the IVAD driveline after learning of pneumatic leaks associated with certain surgical orientations of the pump when used in the paracorporeal position. In one incident a death resulted when a damaged driveline severed at its connection to the pump. Drivelines may be damaged when the driveline connection to the pump impinges on the patient's leg when the patient is in the sitting position. This may cause excessive stress on the driveline, resulting in damage and pneumatic leaks. FDA has been apprised of this action. This action does not affect IVADs implanted in the pre-peritoneal or other internal positions.
Thoratec has received seven reports of damaged drivelines in paracorporeal IVADs, five of which resulted in patient injuries and one in a patient death. These seven reports come from approximately 45 IVADs placed in the paracorporeal position.
Until further notice, Thoratec is voluntarily advising that IVADs not be placed in the paracorporeal position, pending evaluation of any measures needed to prevent additional incidents of this type. Patients who are currently being supported by a Thoratec IVAD placed in the paracorporeal position (i.e. an external pump supporting blood circulation) should immediately contact their doctor. Your doctor will be able to determine if the driveline is properly positioned to minimize the amount of sharp bending. Hospitals were requested in the October 19, 2007 Recall Notification Letter to evaluate the driveline adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles on all patients currently on paracorporeal IVAD support. Hospitals having ongoing patients with IVADs in the paracorporeal position should contact Thoratec for further instructions if they did not receive the October 19, 2007 Recall Notification Letter. Copies of this press release may be found on Thoratec's website, www.thoratec.com, under Investor Relations/Press Releases.
Customers and patients with questions may contact the company at 1-800-528-2577.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Online: www.fda.gov/medwatch/report.htm * Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 * Fax: 1-800-FDA-0178
SOURCE Thoratec Corporation