July 27, 2023

FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath

Editor's Note

The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious.

Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures with this device.

The company reports 26 incidents, 16 injuries, and no deaths related to this issue.

Distribution dates were October 4, 2022, to February 22, 2023.


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