Abbott Recalls Amplatzer Steerable Delivery Sheath On Risk Of Air Embolism

Abbott Laboratories ABT is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles (air emboli) to be introduced into patients who have procedures with this device. 

The Abbott Amplatzer Steerable Delivery Sheath is a cardiac catheter inserted through the skin that provides a pathway for catheter-based devices to be introduced into the heart chambers. 

It is specifically used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.

Also Read: Abbott Laboratories Clocks Strong Q2 Growth In Underlying Base Business, Reaffirms FY23 Outlook.

Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat (tachycardia or bradycardia), low blood pressure (hypotension), and lack of enough oxygen in the blood (desaturation). 

Air embolism can also potentially lead to serious health consequences, including stroke and death.

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

On June 12, 2023, Abbott issued a Medical Device Recall notice and provided the following recommended actions:

• Return any remaining unused Amplatzer Steerable Delivery Sheaths to Abbott. Abbott representatives can assist with the return of these devices.
• Use the fixed curve TorqVue 45°x45° delivery system for future Amplatzer Amulet Left Atrial Appendage Occluder implants.

Abbott will recall 672 devices distributed between October 4, 2022-February 22, 2023.

Price Action: ABT shares are up 0.89% at $113.95 on the last check Wednesday.