Tuesday, February 2, 2021

Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode

Learn more about Boston Scientific's Recall of the EMBLEM S-ICD Subcutaneous Electrode

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US Food and Drug Administration

Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode Due to Risk of Fractures

Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode because of an increased risk of fracture at a specific point. If the device fractures during use, this may lead to serious adverse events, including injury or death.

The FDA has identified this as a Class I recall, the most serious type of recall.

Read the Recall Notice


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