FDA details Class I recall of nearly 240,000 Medtronic ICDs, CRT-Ds
The FDA has announced that Medtronic is recalling multiple implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to an “unexpected and rapid decrease in battery life.” This is a Class I recall, meaning “use of these devices may cause serious injuries or death.”
There have been 444 complaints about these devices so far, including 18 injuries, but no deaths have been reported.
Devices impacted by the recall include Medtronic’s Evera, Viva, Brava, Claria, Amplia, Complia and Visia ICDs and CRT-Ds. The battery issue is caused by a short circuit, the company has said, and can result in full batter depletion within just one day. Users will note that a “Recommended Replacement Time” warning appears when the issue strikes, alerting them that they need to take action.
“If the user does not respond to the first warning, the device may stop functioning,” according to the FDA’s announcement. “The likelihood that this issue will occur is constant after approximately three years after device use.”
Medtronic first initiated the recall, which includes a total of 239,171 devices, in February 2021. All affected healthcare providers were alerted at that time. The devices were all distributed from August 2012 to May 2018.
If patients or clinicians want to learn about how this recall impacts a specific device, they can use Medtronic’s website and look up the serial number.
Read more from the FDA here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.