Thoratec Recall Issued for Defective IVAD Drivers, as Company Indicates it May Recall ProTime System Anticoagulation Monitoring Device As WellNov 16, 2007 | Parker Waichman LLP
Thoratec Corporation has issued a worldwide recall of all of its Implantable Ventricular Assist Device (IVAD) Drivers because the “Instructions for Use” included with the IVAD Drivers included incorrect information. As a result, the recalled Thoratec IVAD Drivers could be implanted incorrectly. The announcement of the Thoratec IVAD Driver recall came just days after the company indicated that it may have to recall another of its defective medical devices, the ProTime System anticoagulation monitoring device.
An implantable ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body. The IVAD 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. According to the Food & Drug Administration (FDA), the recalled Thoratec IVAD Drivers were distributed to 87 hospitals throughout the United States and other countries. The serial number is located on the label of the sterile package and on the driveline’s “Y- connector.” The IVAD recall encompasses all devices with catalog Number 10012-2555-001, serial numbers 488 or higher and manufactured and distributed from October 1, 2004 through October 22, 2007. The Thoratec recall does not affect implanted IVADs.
The FDA has deemed the Thoratec IVAD Driver recall a Class I recall, meaning that these defective devices pose a reasonable probability of causing serious injury or death. According to the FDA, the incorrect “Instructions for Use” indicate that the recalled Thoratec IVAD Driver may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline. These air leaks are a result of sharp bending of the driveline at the connection to the pump. This could result in not enough blood flow to and from the heart.
According to the FDA, Thoratec sent an “Urgent Medical Device” Correction notice to all of its customers notifying them of the problem on October 19, 2007. This notice also included new instructions regarding placement and care of the IVAD driveline. Doctors should contact their patients if any Thoratec IVAD Driver was placed in the external positions.
This is second defective medical device to cause Thoratec problems this month. On November 9, the company said that it had received an FDA warning letter about its ProTime System anticoagulation monitoring device, and may have to recall nearly 6,000 of those faulty devices. The ProTime System is used to monitor patients on anticoagulant therapy. According to Thoratec, the FDA warning letter related to manufacturing and quality issues involving a part from an outside supplier. The defect in the ProTime System could cause it to incorrectly read patients’ blood clotting levels. Thoratec will be meeting with FDA officials soon regarding the ProTime System, and has indicated that a ProTime System recall is likely imminent.