Heart Pump Recalled Amidst Defective Medical Device Allegations
March 4th, 2015|
New medical devices that are being released onto the market must undergo rigorous testing in order to help ensure the products function properly. Unfortunately, not all problems are identified during testing and are only discovered once they are used in a real-world setting. Such issues often result in companies initiating recalls for defective medical devices.
For instance, a company that manufactures a heart pump—Heartware—has announced the recall of the 1400 and 1401XX Ventricular Assist Systems (VAS) after discovering an electrical malfunction that could be extremely harmful to the patient.
According to the U.S. Food and Drug Administration, the device is prone to a glitch that can cause data errors when it is exposed to a discharge of static electricity. The glitch can lead to the pump not functioning as it was designed, which can in turn result in the patient being seriously injured or killed. It’s estimated that as many as 120 patients could be affected by the defective heart pump.
In response to the problem, health care providers who supplied patients with the device are being instructed to inform those individuals of the recall and to discuss with them how they can reduce the chances of a static electricity discharge. The device should also be exchanged for a new one. Patients are also being given instructions on how to handle the faulty units.
It’s important to remember this information may come too late for some patients whom the device has already harmed and it’s important for those individuals to know that help is available. At Fleschner, Stark, Tanoos & Newlin, we have a team of Terre Haute personal injury attorneys who are standing by to answer any questions you may have regarding the legal processes of filing a claim for compensation if you’ve been injured by a defective medical device. Call us today for a free consultation of your case at (800) 477-7315.