Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

Abbott is recalling the steerable sheath used to deliver its Amplatzer Amulet Left Atrial Appendage Occluder, saying there is an increased risk of air emboli being introduced to patients undergoing these procedures. The US Food and Drug Administration today classified this action as a Class I recall, its most serious type.

Abbott issued the recall notice June 12, 2023, asking sites to return any unused steerable sheaths and specifying that the fixed-curve TorqVue 45° x 45° delivery system can be used for any future Amplatzer Amulet Left Atrial Appendage Occluder implantation procedures.

In all, 26 incidents, 16 injuries, but no deaths have so far been attributed to the defective product, yielding an overall reported incidence rate of 0.77%, the recall database entry notes. “Within those cases, customers have reported air emboli having resulted in transient ST-segment elevation resolving spontaneously and, less commonly, hemodynamic instability requiring medical intervention. There have been no reported cases of permanent injury or fatality due to air embolism,” the Abbott letter to healthcare professionals clarifies.

A total of 672 sheaths distributed between October 4, 2002, and February 22, 2023, are on the US market (product model: ASDS-14F-075).