PLEASANTON, Calif., July 19 /PRNewswire-FirstCall/ -- Thoratec Corporation is providing an update on a voluntary, worldwide recall initiated on April 9, 2007 of all paracorporeal Ventricular Assist Devices (PVAD) manufactured and distributed prior to October 2006. The firm voluntarily recalled the products after learning of continuing incorrect collet nut assembly during surgical implantation. Use of the wrong size collet nut to secure the inflow cannula to the PVAD has resulted in three patient deaths since 1996. FDA has been apprised of this action.
The PVADs manufactured prior to October 2006 included black collets and collet nuts used to secure the cannula to the pump that have been involved in several reports of incorrect assembly with the inflow cannulae during surgical implantation, which has in three cases resulted in severe bleeding and death.
Patients who are currently being supported by a Thoratec paracorporeal Ventricular Assist Device should immediately contact their doctor. Your doctor will be able to determine if a black collet and collet nut was used when the device was implanted. Hospitals were requested in the April 9, 2007 Recall Notification Letter to check for proper cannulae connections on all patients currently on PVAD support. Hospitals having affected PVADs in inventory should contact Thoratec for further instructions if they did not receive the April 9, 2007 Recall Notification Letter.
The recall affects 2,484 PVADs, Catalog No. 14086-2550-000, bearing serial numbers of 10745 or less.
The affected PVADs were distributed directly to 149 hospitals throughout the United States and other countries. They can be identified by a black collet nut on the inflow port of the PVAD and also by the serial number located both on the label of the sterile package and on the PVAD itself.
Thoratec notified its customers of the recall by letter on April 9, 2007 and is arranging for the application of conspicuous warning labels to all recalled product remaining in hospital inventory. Thoratec’s records indicate that as of July 13, 2007, the application of warning labels to affected PVADs is 92% complete.
Customers and patients with questions may contact the company at 1-800-456-1477.
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: http://www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 -- Fax: 1-800-FDA-0178
Thoratec Corporation
CONTACT: Thoratec Corporation, Customer Service, 1-800-456-1477
