FDA Update: Agency Announces Recall of Medtronic ICDs and CRT-Ds With Glassed Feedthrough
The U.S. Food and Drug Administration (FDA) on July 18 announced a recall by Medtronic of all ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough due to risk of low or no energy output during high voltage therapy.
These devices, intended to monitor and regulate heart rate and rhythm, are more likely to experience this issue if they have a glassed feedthrough and are configured to deliver therapy in the AX>B delivered pathway. The agency has identified this as a Class I recall, meaning use of these devices may cause serious injury or death.
For more information and agency recommendations, access the FDA website.
Keywords: Device Approval, United States, Durable Medical Equipment, United States Food and Drug Administration, ACC Advocacy
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