Olivia Esposito • August 4, 2023
Medtronic ICD Recall

What 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™/Crome™ICDs and CRT-Ds, a subset of: Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava™CRT-Ds, a subset of: Visia AF™/Visia AF MRI™/Evera™/Evera MRI™/Primo MRI™/Mirro MRI™ICDs. 

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.  

By Sabrina Cuddy December 23, 2024
You must advocate for yourself to get the best care for your HCM. The first step is to have a plan that includes the tests you need and how often to see your cardiologist. To make planning easier, the HCMA offers Navigation Calls. We encourage everyone with HCM to complete our Intake and Navigation Call at least… The post The HCMA theme for January is Setting Your Plan For The Year appeared first on Hypertrophic Cardiomyopathy Association.
By Sabrina Cuddy November 20, 2024
Why practice gratitude? Gratitude has benefits for both mental and physical health as well as our relationships with those around us. When we’re thankful for anything positive in our lives, it leads to a shift in mindset that helps us feel better and take action to stay as healthy as possible. What can you think… The post The HCMA theme for December is Gratitude appeared first on Hypertrophic Cardiomyopathy Association.
By Sabrina Cuddy November 5, 2024
At the HCMA, November is when we’re thinking about weight management. We all know that winter months and holiday foods can lead to potential weight gain, and it happens to the best of us. It’s easy to gain weight with all the less healthy options in front of us – face it, we all love… The post Holiday Weight Management appeared first on Hypertrophic Cardiomyopathy Association.
More Posts
Share by: