November 6, 2008
Thorteca Corporation has issued a warning regarding the HeartMate II Left Ventricular Assist Systems (HM II LVAS) with Catalogue No. 1355 or 102139, due to the risk of defective medical device injuries.
The device’s percutaneous lead which connects the device to the systems controller could wear overtime and cause interruption in the pump function, further causing serious injuries or death due to defective medical devices.
The devices responsible for the possible defective medical device injuries were distributed to 153 hospitals and distributors in the United States.
Texas patients who had the devices used on them in Texas hospitals could experience Texas defective medical device injuries if the devices are not properly replaced.