Healthcare Industry News: Thoratec
News Release - July 19, 2007
Thoratec Corporation Provides Update on Worldwide Recall of TLC-II Portable VAD DriverPLEASANTON, Calif., July 19 (HSMN NewsFeed) -- 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.
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
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