PLEASANTON, Calif., July 19 /PRNewswire-FirstCall/ -- Thoratec Corporation is providing an update on a voluntary, worldwide recall that was initiated on June 8, 2007, of 378 TLC-II Portable VAD Drivers, Cat. No. 20010-0000-132. Thoratec initiated this recall due to increased reports of premature motor failure, which can result in loss of VAD support for the patient’s circulatory system with the potential for serious injury or death. To date, Thoratec has received 21 reports of this type of malfunction. The recall involves shortening the service interval on the TLC II from 3,000 hours down to 1,500 hours. The 1,500 hour service interval is under review by the Food and Drug Administration.
Patients on VAD support with a TLC-II Driver should ensure they have a back-up driver and hand-pumps available at all times and should immediately contact their hospitals to ascertain if their device is affected by this recall. Hospitals were instructed in the June 8th Recall Notification Letter to check their current inventory and their on-going patients and not to use drivers that have exceeded 1500 hours of use. Additionally, hospitals were instructed to contact Thoratec to arrange for servicing of any affected TLC-II Drivers. Customers who have already complied with the instructions outlined in the June 8th Recall Notification Letter do not need to take any further action. FDA has been apprised of this action.
Thoratec had previously notified all its US customers on June 8th of this corrective action and has received acknowledgement forms from 77% of such customers. To date, 25% of the affected TLC-II Drivers have been serviced and we are committed to 100% effectiveness checks and will be following up with customers who have not responded.
All TLC-II Drivers manufactured or serviced since September 2005 are affected by this recall. The affected TLC-II Drivers were distributed directly to hospitals throughout the United States and other countries. Hospitals should refer to the recall notification sent to customers on June 8, 2007, to determine identification of affected TLC-II Drivers or they may contact Thoratec Customer Service at the toll-free number listed below if they have any questions regarding identification of affected drivers.
Thoratec has notified its distributors and customers by letter and has plans in place to complete the service updates on all remaining affected product in distribution.
Customers or 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: http://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
