Thoratec IVAD Recall
A nationwide recall has been issued for Thoratec Corporation Implantable Ventricular Assist Devices (IVAD), as a design defect could lead to an interruption of proper blood flow to the heart when the device is placed in the external position. The Thoratec IVAD recall was classified by the FDA as a class 1 recall, since there is a reasonable probability that use of the product will cause serious injury or death.
The Thoratec IVAD is a heart device which can be used as a bridge-to-transplantation or for recovery from open heart surgery. It aids weak hearts by using a mechanical, air-powered pump to move blood through the body.
Thoratec marketed their IVAD to be implanted internally in the pre-peritoneal position, or externally in the paracorporeal position. If the IVAD is external, the driveline could be exposed to incidental stress which could cause blockages and leaks in the hose. This could occur if the driveline to the pump impinges on the patient’s leg when they sit down, causing an interruption of circulatory support.
The Thoratec IVAD recall applies to models containing a Catalogue number 10012-2555-001 and serial numbers 488 or higher, which can be idenfitied on the label located on the driveline’s ‘Y-connector’. Over 4200 of the Thoratec IVADs were sold directly to 87 hospitals, and have been used by nearly 3,000 people between October 1, 2004 and October 22, 2007.
At least one death has been reported and five other serious injuries out of seven known incidents where the driveline was damaged. The seven failures occurred out of 45 reported IVADs placed in the external position.
The Thoratec recall advises that IVADs should not be used as an external pump to support blood circulation due to the risk of serious injury. The company is evaluating measures needed to prevent more problems like this, and those who are currently being supported by an external Thoratec IVAD have been advised to consult with their doctors to make sure that the driveline is properly positioned to reduce the risk of a sharp bend.
If you, a friend or family member have suffered a serious injury or death as a result of an external Thoratec IVAD placement, request a free consultation.