Medtronic has recalled about 348,000 implantable cardiac defibrillators that may deliver low shocks, or no shock at all, when a person experiences a life-threatening irregular heartbeat.
There were 28 incidents and 22 injuries reported, but no deaths. Even so, the problem could be deadly, according to the FDA:
“A reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death.”
The FDA also warned about other risks, such as additional surgical procedures to remove and replace the defibrillator.
The recall involves certain implantable cardioverter defibillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) that were distributed between October 2017 and June 2023.
These device may deliver inadequate low-energy shocks, or no shock at all, due to problems with a feature that is supposed to prevent short-circuits, according to the FDA.
The list of defibrillators being recalled include the Cobalt, Cobalt XT, Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-Ds; and the Visia AF and Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs.
Source: Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy