In April 2021, the U.S. Food and Drug Administration (FDA) announced a
Class I recall Medtronic’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices.
ICD devices deliver strong jolts to defibrillate a stopped or quivering heart or deliver mild electric pulses to regulate a heartbeat that is too fast (tachycardia) or too slow (bradycardia). CRT-D devices are a more complicated version of ICDs. They are designed to treat advanced heart failure by delivering electrical pulses to both sides of the heart. The devices are implanted under the skin in the upper chest region with connecting insulated wires known as “leads.” The leads go into the heart to transit the electrical pulses.
The recall is due to the rapid and unexpected decrease in battery life. The devices are powered by lithium batteries which are supposed to last for 7-12 years. However, defects in the batteries have caused the device to short-circuit. In response, the FDA issued a Class I recall–the most serious FDA recall.
Medtronic said that the decrease in battery life is due to the short-circuiting and will cause some devices to produce a “Recommended Replacement Time” (RRT) earlier than normal for the devices. RRTs are the first warnings that the device’s battery is low. Some of the devices included in the recall may transition from the “Recommended Replacement Time” warning to full battery depletion as quickly as one day. Medtronic also said that if the user does not respond to the RRT, the device may stop functioning.
Class I Recall
A Class I recall is the most serious recall the FDA can issue and it means that the use of these devices can cause serious injuries or death. The FDA reported that there have been 444 complaints regarding these devices. There are 264 Medical Device Reports with 18 people reporting injuries, including bradycardia (slow heart rhythm) and heart failure symptoms. The FDA said that no deaths have been reported.
Medtronic’s recall includes Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) devices distributed between August 31, 2012, and May 9, 2018– encompassing 48 specific units linked to the manufacturing defect. The defect makes the gas mixture inside the device unable to deliver the electrical charge needed to revive a patient in cardiac arrest or stimulate a heart that is beating too slowly. Medtronic cannot identify which of the 48 recalled devices are actually prone to failure nor when the failure may occur. Initial testing has revealed failures occur in 23% of the devices, with 7.7% failing after just two charges.
There are 339,000 implanted devices worldwide that could potentially be susceptible to this issue. Based on confirmed events, Medtronic projects approximately 0.2% of affected devices may experience this problem.
In February 2021, Medtronic issued an urgent medical device correction letter to healthcare providers urging them to continue normal follow-ups with their patients and perform prompt replacements of devices that have given RRT warnings. Medtronic recommends that replacements should be conducted within one week for non-pacing-dependent patients or primary prevention ICD patients, but the replacements should be performed immediately for pacing-dependent patients.
ICD devices include:
CRT-D devices include:
How GoldenbergLaw Can Help
If you or a loved one suffered harm from a Medtronic ICD or CRT-D heart device, contact the Defective Medical Device Attorneys at GoldenbergLaw. Our team has over 30 years of experience providing the Gold standard of advocacy for our clients. Contact us today for a free consultation!