Class 1 Recall: Thoratec® Paracorporeal Ventricular Assist System (PVAD)

March 30, 2007

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.

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.

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).

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