The FDA has introduced a Class I recall of sure fashions of Medtronic implantable defibrillators and cardiac resynchronization remedy defibrillators. The assertion from the FDA might be discovered right here.
The recall impacts 348,616 gadgets implanted between October 13, 2017 to June 9, 2023 with the next fashions being affected:
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
These gadgets fail to ship remedy on account of inappropriate activation of the Quick Circuit Safety characteristic. The problem is extra more likely to happen for gadgets with a glassed feedthrough which can be configured to ship remedy within the AX>B delivered pathway.
A reduced-energy shock, or no shock in any respect, might fail to appropriate a life-threatening arrhythmia, which might result in cardiac arrest, different critical damage, or loss of life.
There have been 28 incidents, 22 accidents, and no deaths for this challenge.
A software program replace delivered to your system will handle the problem. This requires a go to to your well being care practitioner for a fast replace. I had mine up to date in a fast 10 minute go to to my ICD clinic.
To lookup your system by product identify, mannequin or serial quantity to see whether or not it’s impacted, click on right here.
NOTE: You could find the identify, mannequin and serial variety of your system on the plastic identification card offered to you on the time of your implant.
The field within the higher proper nook labeled “Buyer Communications For This Mannequin” will let you know if there are any advisories on your system. If this explicit recall impacts your system, you will notice the identical advisory which is circled in pink within the photograph beneath.
Sufferers are suggested to proceed routine observe ups and use the Care Hyperlink Monitoring System.
And, as all the time, you possibly can name Medtronic Affected person Providers with any questions at: (800) 551-5544
(M – F, 8am – 5pm Central).