On June 29, 2019, Abbot issued a recall of their Ellipse Implantable Cardioverter Defibrillators (ICDs) due to an issue with faulty wiring. The ICDs are similar to Pacemakers. They detect rapid heartbeats and when they occur, send a small electric shock to the heart. This shock returns the heartbeat to its normal rhythm. Without these devices, cardiac patients could suffer from a heart attack or stroke, two conditions that could be fatal. However, those consequences could result when the devices are faulty, too.
The issue with the ICDs identified in the latest recall is that some of the wiring was not properly insulated. That left some wires exposed, which would result in the device not working properly. When the wires are exposed, the ICD cannot send the shocks to the heart that return the rhythm back to normal. Unfortunately, there is no way to determine whether a device is faulty or not before it is implanted in a patient.
“This type of defect in a medical device is disastrous for patients,” said product liability lawyer Ryan McKeen of Connecticut Trial Firm. “When patients rely on a product to save their life, and that product is defective, it provides a sense of false security. These defects also have tragic results, and there are only more recalls occurring every year.”
That is a fact. In both 2017 and 2018, there were 32 device recalls each year. This year that number has increased by one, as currently there have been 33 device recalls. However, the year is not over yet, and there could be even more by the time New Year’s Eve rolls around.
Of the 108 devices that were recalled in this latest announcement, 31 were implanted in patients in the United States. Abbott has stated that it has not received any reports of patients being harmed in the United States due to the devices. The company also said that most of the defective devices issued have been replaced, or are about to be replaced. Unfortunately, when it comes to these devices that are supposed to be life-saving, not everyone is always so lucky.
