Medtronic is recalling all implantable cardioverter defibrillator (ICD) and cardiac resynchronisation (CRT-D) devices manufactured after 2017 with a glassed feedthrough, as there is a risk that the devices may deliver low or no energy output when high voltage therapy is needed.
The details of the recall are contained in a notice on the US Food and Drug Administration (FDA) website, in which it is identified as a Class I recall, the most serious type of recall. In total, Medtronic has reported 28 incidents, including 22 injuries, but no deaths related to this issue.
In its notice, the FDA states: “Medtronic is recalling all ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough, as they may deliver low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature. The issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway.
“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. There are additional risks of harm if a patient with one of these devices needs additional surgical procedures to remove and replace the device.”
