Medtronic recalls 348K defibrillators over concerns they deliver reduced, no shock
MINNEAPOLIS -- Medtronic has issued a recall for over 348,000 defibrillators because there is a risk they deliver low shock, or no shock at all.
The Class I recall - the most serious type of recall issued by the Food and Drug Administration - applies to some implantable cardiac devices that are meant to monitor and regulate heart rate and rhythm. They are supposed to produce an electric shock to restore normal heartbeat.
The recall impacts the following products distributed between Oct. 13, 2017 to June 9, 2023:
- Cobalt XT, Cobalt, Crome ICDs and CRT-Ds
- Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds
- Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs
"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 recall notice says.
In all, there have been 28 incidents that have resulted in 22 injuries. There have been no deaths due to the issue.
Medtronic initiated the recall on May 10.
For more information on the recall and what to do if you are impacted, click here.