Source | FDA

Date Recall:  Initiated June 8, 2007
 
Product: 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.).
 
Use: 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.
 
Recalling Firm: Thoratec® Corporation, 6035 Stoneridge Drive, Pleasanton, California 94588

Reason for Recall: 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. 

FDA Comments: 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

Do I have a Thoratec VAD or PVAD Lawsuit?

If you or a loved one have been injured or killed by a Thoratec cardiac device, you should contact us immediately. You may be entitled to compensation and we can help.

Source | FDA

Date Recall:  Initiated March 30, 2007
 
Product: Thoratec® Paracorporeal Ventricular Assist System, (PVAD) Model TLC-II®, Catalog No. 14086-2550-000, manufactured from January 1, 2004 through October 2, 2006, and with expiration dates of January, 2007 to October, 2009.

From January 2, 2004 through February 23, 2007, 2484 units were distributed to 146 customers (distributors, hospitals and medical centers), 123 customers within the U.S. and to 23 customers outside the U.S. PVADs with serial numbers 10745 or less were shipped after January, 2004.
 
Use: The PVAD is a part of the Vascular Assist Device. 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. The device is also used for patients who are recovering from heart surgery and must continue on a heart-lung machine.
 
Recalling Firm: Thoratec® Corporation, 6035 Stoneridge Drive, Pleasanton, California 94588

Reason for Recall: The PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use. The blood is pumped from the VAD through the cannula into the patient. (The black collet is similar to how a washer works with a nut. It is called a black collet because the collet and matching nut are painted black for easy identification). 

FDA Comments: The company has issued an “urgent medical device correction” notice to all VAD customers alerting them about the problem. The letter instructs customers that a Thoratec® representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs the customers to dispose of any expired original design cannula and:

• not use the black collet and nut with any design VAD
• make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula
• provide a copy of the product safety bulletin to all hospitals and/or physicians that may be following patients implanted with PVADs, and
• provide contact information with the acknowledgement form  

Once the company calls the hospitals and/or medical centers, it is up to the individual doctors to contact their patients.

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

Do I have a Thoratec PVAD or VAD Lawsuit?

If you or a loved one have been injured or killed by a Thoratec cardiac device, you should contact us immediately. You may be entitled to compensation and we can help.