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.  

HCMA Blog

By Lisa Salberg July 3, 2025
Summer, greetings to all our big-hearted friends As July approaches, our focus is already on the fall and preparing for some major events, including our annual meeting coming up in October. July will also find us on the west coast in Seattle conducting a regional patient education meeting as part of our big-hearted warrior tour. We have been following the generic drug quality issue in the United States very closely and encourage you to watch the series starting with our Hill briefing in April and following with the additional webinars with our partners at Medshadow and the People's Pharmacy, and of course the ProPublica series of articles. See them all here . We are happy to have a new team member on board - we welcome Pam as our coordinator of both our All Hearts Collaborative and Hearts and Minds project. Over the next few months, you're going to be learning more about these two amazing initiatives and how we are working to provide better services for big hearts regardless of where you live, so we are meeting all of our big-hearted friends where they are. Please stay tuned for updates from these projects coming soon. We are also creating new volunteer opportunities and engagements that we hope will make it easier for you to participate in spreading the message of the importance of diagnosis, the importance of community readiness related to CPR and AED use and, of course, helping patients get to their ultimate diagnosis and getting them on the proper treatment pathways. This July I would like to recognize all of the special birthdays in my family, including HCMA Center of Excellence coordinator, Stacey Titus-brown and my daughter Rebecca Salberg. It's a milestone birthday for Becca - it’s hard to believe I have a 30-year-old child. Wishing you all a happy and healthy summer. Go build some memories!
An official seal in black  & red with white letters that say HCMS Recognized Centers of Excellence
By Sabrina Cuddy July 3, 2025
Getting HCM care at a HCMA Recognized Center of Excellence has a positive impact on patient's outcomes. Find out why in the post by Health Educator Sabrina Cuddy
By Erica Friedman June 26, 2025
Investigative journalists Debbie Cenziper, Megan Rose, Brandon Roberts and Irena Hwang from Pro Publica and NPR have concluded a 14-month long investigation into the quality of generic drugs coming into the United States from overseas. Among the many voices that spoke up for American patients was HCMA Founder and CEO, Lisa Salberg who has felt the effects of low-quality drugs personally. Salberg believes that fixing this problem is something we can do, even in this time, when even health care is highly politicized. Read the key takeaways from ProPublica’s 14-month investigation into the FDA’s oversight of foreign drugmakers in Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs .
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