FDA identifies Abbott’s recall of heart catheter as Class 1

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled product

• Product Name: Amplatzer Steerable Delivery Sheath
• Product Model: ASDS-14F-075
• Distribution Dates: October 4, 2022 to February 22, 2023
• Devices Recalled in the U.S.: 672
• Date Initiated by Firm: June 12, 2023

Device use
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 chambers of the heart. It is specifically used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.

Reason for recall
Abbott 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.

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.

Who may be affected

• People having cardiac catheterization procedures with the Abbott Steerable Delivery Sheath.
• Healthcare providers who planned to use the Abbott Steerable Delivery Sheath for cardiac catheterization.

What to do
On June 12, 2023, Abbott issued a Medical Device Recall notice to customers. The communication provided the following recommended actions:

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

MB Bureau