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Thoratec Corporation voluntarily issued an Urgent Medical Device Correction notice of the Heartmate II Left Ventricular Assist System (LVAS). The urgent correction notice follows 27 reports of wear and fatigue to the piece responsible for connecting the Heartmate II LVAS blood pump to the System Controller.
According to a press release issued by Thoratec, damage to the connecting piece, or the percutaneous lead, could result in a malfunction of the blood pump, which could, in turn, lead to serious injuries or death. Of the 27 patients who reportedly experienced defective blood pumps, 22 had successful replacements and five died.
History of the Heartmate II LVAS
Thoratec began conducting clinical studies of the Heartmate II LVAS in November 2003 and have, since, installed 1,972 devices in patients throughout the U.S., Europe, Canada and other countries.
Thoratec is encouraging all patients living with a Heartmate II LVAS to contact their doctors immediately for a full evaluation of the pump. According to the corporation, there is an increased probability that damage to the percutaneous lead has occurred in patients who have had the pump installed for longer periods of time.
Following is the estimated probability of the need for a pump replacement:
Corporation Alerts Hospitals of Potential Risks
Thoratec is in the process of sending the Urgent Medical Device Correction letter to all hospitals that have ordered the Heartmate II LVAS and are strongly advising that they inform all patients supported by the pump of its problems. Medical professionals who have not received the letter are advised to contact Thoratec for information and further instruction. The II LVAS pumps that are in question have Catalogue No. 1355 or 102139.
According to Thoratec, they will be developing new packaging for the blood pump that will include all possible risk factors printed on the label. All doctors who have and continue to use the pump are encouraged to thoroughly discuss the instructions for care with their patients and should regularly check for any possible damage.
Are you or someone you love being supported by a Heartmate II LVAS? If so, contact your physician immediately to get a complete examination. If you or your loved one has been harmed by the Heartmate II LVAS, or by another defective medical device, contact us today to speak with an experienced personal injury attorney who will ensure you legal rights are protected. Our attorneys have been successfully representing individuals who have suffered injuries or lost loved ones due to defective medical devices for decades and are standing by to help you.
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