Defibrillators—or medical devices capable of sending an electrical current through the body to jolt the heart back into rhythm—were groundbreaking in improving the lives of patients with heart conditions. Unfortunately, numerous design flaws have been discovered with these devices, leading to recalls and legal action.
One of the defibrillators known to have problems is the Riata™ defibrillator manufactured by St. Jude Medical, Inc. Roughly 79,000 patients received the device by 2011 when a nationwide recall was initiated due to erosion of the insulation surrounding the electrical wires of the unit. This erosion was capable of causing multiple injuries including electrical shocks, infections, perforation of muscle, and the migration in the body of the unit or it’s parts. Some of those who suffered injuries as a result of these failures later filed Riata™ defibrillator lawsuits against the maker of the product.
Issues like these have prompted the U.S. Food and Drug Administration (FDA) to take action to prevent injuries from the use of defibrillators in the future. KBTX News reports that defibrillator manufacturers must now submit data regarding testing of battery life, adapters, and electrodes in order to receive final approval from the agency to sell the product. The FDA hopes the move will improve safety of defibrillators.
At Daniel Stark Injury Lawyers, we’ve seen injuries caused by defective medical devices, and our College Station personal injury lawyers applaud the efforts being made to improve the safety of defibrillators on the market.