Class 1 Recall: Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver

June 8, 2007

Thoratec® TLC-II® Portable Ventricular Assist Device (VAD) Driver, Catalog Number 20010-0000-032.

From September 1, 2005 through June 4, 2007, Thoratec® distributed 378 VAD units to 378 hospitals (251 within the U.S and 127 outside the U.S.).

A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. The VAD is designed to provide sufficient blood flow to the damaged or diseased heart. It is sometimes referred to as a “bridge to transplant” since it can help a patient survive until a heart transplant can be performed.

VAD support for the patient’s circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning. When the motor fails, there is a loss of VAD support for the patient. This results in inadequate blood flow to and from the heart.

Thoratec® notified most hospitals (77% acknowledgement) regarding servicing of their current inventory of the TLC-II Portable VAD Drivers. The hospitals must:

• check the current number of service hours on all units
• not use the TLC-II® drivers exceeding 1500 hours until they are serviced by Thoratec®
• note the indicated number of hours on the product inventory form and return the form to Thoratec®
• ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures.

Thoratec® has arranged for the return and servicing of all affected drivers, with the highest priority to those drivers already exceeding 1500 hours. There is a risk of the driver to fail between 1500 and 3000 hours.

When the 1500 hour limit has been reached, patients must stop using the device and then send it to the manufacturer for servicing. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement.

A patient must have a back-up or hand pump in their possession at all times. If the switch does not take place fast enough (within a minute), the patient may suffer a stroke or brain damage.

Patients just receiving these units should inquire when the alarm will notify them of the need for servicing. If the driver is programmed to alarm at 3000 hours, then be sure to change the driver to the backup replacement unit at 1500 hours and obtain a new backup replacement driver.

Doctors should be contacting their patients about this device. If patients have any questions, they should contact their doctor.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product 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