In June, Abbott recalled their Ellipse implantable cardioverter defibrillators (ICDs) due to an electrical failure. It was the 33rd recall of a medical device for the year, showing just how common it is for medical devices to be defective. This recall was released because a faulty manufacturing process caused some of the aluminum wires to be partially exposed.
An ICD is a device that detects when a person’s heartbeat is beating too rapidly, which can be life-threatening. If it does detect a fast heartbeat, it sends a quick electrical shock to the heart. This current normalizes the heartbeat. The faulty exposed wire could short out, meaning that it would not be able to send out that shock.
“This just proves how easily a product can be defective,” says Charles Boyk, an Ohio personal injury attorney of Charles E. Boyk Law Offices, LLC. “It also proves the serious harm that can result when they are. When patients are not receiving the small shocks to their heart they need, it can result in heart failure or stroke. Countless lives could be lost unnecessarily because manufacturers were negligent.”
So far, Abbott has stated that no patients have been adversely affected by the defective ICDs. Thirty-one of the implants that have been recalled are being used by patients in the United States. Many of those have already been replaced.
In total, 108 Ellipse ICDs were recalled. These were manufactured between April 5, 2019, and May 29, 2019. They were given to patients between May 6, 2019, and June 14, 2019. Although the recall was issued in June of 2019, a study out of St. Jude found that there were likely defects with the device in March of the same year.
Although 31 devices may not sound like a lot, it is a number that has increased. In both 2017 and 2018, there were only 32 device recalls during each year. That news is alarming for anyone that has cardiac problems and needs a device to be installed.
The FDA monitors and publishes recalls. In the wake of this most recent recall, the agency has stated that they are committed to improving the process of notifying the public of recalls.