TranslateWhat is the recall : The FDA has issued a Class 1 recall of Medtronic ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough.
Who does it affect
: This recall affects only
the following Medtronic ICDs: Cobalt
XT/Cobalt/CromeICDs and CRT-Ds, a subset of: Claria MRI/Amplia MRI/Compia MRI/Viva/BravaCRT-Ds, a subset of: Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRIICDs.
Why are these devices recalled : These devices were recalled because they may deliver low or no energy output when high voltage therapy is needed. This is due to inappropriate activation of the Short Circuit Protection (SCP) feature.
How to check if it affects me : You can find this information on the device card you received when your device was implanted. You can visit the Medtronic website here to look up your device by product name, model or serial number to see if your device is affected.
What should I do if it affects my device : If your device is affected by this recall, you should receive a letter in the mail or a call from your device clinic. If you have not received a letter or call, you can always reach out to your clinic.
What is being recommended : Medtronic is not recommending replacement of these devices.They are recommending that patients with the affected ICDs continue with routine remote monitoring and in-clinic visits. Reprogramming can be performed at your in-clinic visit, if needed.
You can read more about the Medtronic recall here.
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