In June 2022, Medtronic began alerting physicians to the potential for reduced shock energy during therapy in its Cobalt™ and Crome™ portfolio of ICDs and CRT-Ds, along with comprehensive patient management recommendations. At the same time, Medtronic asked hospitals to quarantine and return a subset of non-implanted Cobalt and Crome devices for inspection.

The FDA recently designated this voluntary action by Medtronic as a Class I recall. There have been no reports of permanent patient harm or deaths due to this issue.

Medtronic has received FDA approval and CE Mark for a software update to help mitigate this issue. The company began deploying the update into already-implanted Cobalt XT, Cobalt, and Crome devices via in-clinic device checks in mid-August 2022. Newly manufactured devices will have the update pre-installed starting this month.

In the original communication, Medtronic instructed physicians to set these devices at maximum energy output (40 joules); by programming to maximum output, the impact on the devices’ effectiveness is minimal (e.g., 99% efficacy to 98% efficacy) if the issue occurs.

CONTACTS:
Tracy McNulty, CRM
Kathleen Janasz, CRM