The FDA has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries or death.
Medtronic’s ICDs and CRT-Ds are implantable cardiac devices that monitor and regulate heart rate and rhythm.
These devices automatically detect and treat life-threatening irregular heartbeats (arrhythmia) by producing an electric shock (cardioversion or defibrillation) to restore a normal heartbeat.
Some devices can also provide cardiac resynchronization therapy to treat heart failure.
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 for devices with a glassed feedthrough 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.
Medtronic has reported 28 incidents, 22 injuries, and no deaths for this issue.
The recall impacts around 350k devices distributed between Oct. 13, 2017-June 9, 2023.
Price Action: MDT shares are down 0.95% at $85.89 at the time of publication on Tuesday.
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