Urgent Medical Device Correction – Heartmate II

Thoratec Recently Issued a Voluntary Device Correction, What This Means for You

Thoratec Corporation (NASDAQ: THOR) recently put out an Urgent Medical Device Correction Letter to hospitals across the country, informing them of a defect from their Heartmate II LVAS device, specifically the backup System Controller battery system.  From the FDA Safety Recall Notification:

 

On September 1, 2015, Thoratec received reports from several hospitals about a number of patients who encountered an advisory alarm due to the expiration of their System Controller backup batteries. Some of these patients who received the advisory alarm attempted to switch from their primary to backup System Controller, and of those, three were unable to connect their pump to their backup System Controller in a timely manner, resulting in two patient deaths and one serious injury.

 

These types of incidents do happen which is exactly why the notification systems were put in place; to mitigate the risk to patients who use medical devices or drugs.  It is extremely unfortunate whenever a product of this type has a life-threatening defect. In most cases, the products were tested thoroughly and these defects are anomalies.  However, having three deaths so close together due to a product defect does not bode well for Thoratec’s quality control and device testing rigor.

 

Thoratec is a company that specializes in products and devices which treat advanced stage heart failure.  The level of trust assumed by companies like Thoratec is immense.  They are given the responsibility of maintaining life with their products.  The company currently has approximately 20,000 devices that have been implanted in heart patients all across the country, all of which are using this system.  It is imperative that information about the device recall be disseminated so that all heart patients and their families have an opportunity to read the material and make –quick– wise choices regarding their own health.

 

When individuals have been injured by medical devices or drugs and those devices were put to market with reservations or without fully informing the public of risks associated with the device, those individuals or their families have a right to seek compensation in a court of law. Personal injury attorneys routinely work with families to gain just compensation when a company has failed to adequately warn the public or distributed a faulty product.  Time will tell whether or not Thoratec is responsible for the deaths associated with the product, however, the number of deaths associated with the devices in a short time frame does create a legal question for their families about responsibility and liability for this device.

 

Families and individuals who use the  Heartmate II LVAS device should contact their physician immediately.  If you have been using this product and are curious about your legal rights, you are always welcome to call our office and speak to someone today.