Abbott Cardiac Catheter Recall Issued Over Embolism Risks

FDA has categorized the action as a Class I Medical Device Recall, after dozens of reports involving problems with Abbott cardiac catheters leaking air inside a patient’s bloodstream, resulting in a risk of serious injury or death

Federal health officials have announced a recall of nearly 700 Abbott cardiac catheters, following at least 26 of reports involving the devices leaking air bubbles into the bloodstream during medical procedures, which increases the risk of an air embolism event and may lead to life-threatening health consequences.

The Abbott catheter recall was given a Class I designation by the U.S. Food and Drug Administration (FDA) on July 26, warning health care professionals that continued use of the devices have a high probability of resulting in serious injury or death.

The cardiac delivery sheaths are steerable catheters inserted through a patient’s skin, designed to work in conjunction with Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder implant, and provides a passageway for permanent heart implants to be inserted into the heart chambers during cardiac procedures.

According the recall notice, the catheter’s hemostasis valve, which was designed to minimize blood loss but were not intended to prevent air ingress, can leak air  bubbles into the patient’s bloodstream during medical procedures, which can travel to the heart and cause an air embolism.

Officials warn that the introduction of air bubbles within the bloodstream can result in severe injuries, including sudden disruption of blood flow to the heart, changes to the heartbeat, low blood pressure, and insufficient blood oxygen levels. In addition, officials indicate an air embolism can also lead to potentially life-threatening consequences, including stroke or death.

Abbott Cardiac Catheter Recall

The recall affects approximately 672 Abbott Amplatzer Steerable Delivery Sheaths, including product model ASDS-14F-075, which were distributed from October 4, 2022 until February 22, 2023.

To date, the medical device manufacturer has received at least 26 complaints in relation to the defective catheters. While no deaths have been reported, Abbott has become aware of at least 16 incidents that resulted in injuries due to the air leaking catheters.

Abbott has instructed medical professionals to stop using the catheters immediately, and use the fixed TorqVue 45°x45° delivery system to perform future Amplatzer Amulet Left Atrial Appendage Occluder cardiac implant procedures.

For more information on the recall, customers are encouraged to contact their local Abbott customer service representative, or they may also contact Abbott’s customer support by phone at 1-800-544-1664, and choose the second option to speak to a representative.

The FDA is also calling on consumers to report any adverse side effects, reactions, or quality defects experienced while using the devices to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online reporting form.