16 injuries lead to Class I recall of Abbott heart device

Abbott recalled 672 cardiac catheters because of an increased risk of air bubbles, which can affect a patient’s heartbeat and blood pressure, the FDA said July 26.

Advertisement

The product, the Amplatzer Steerable Delivery Sheath, delivers Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder. 

Air bubbles can lead to sudden reduction in blood flow to the heart, a fast or slow heartbeat, low blood pressure, and desaturation, the FDA said. These can lead to stroke and death, which classifies the recall as Class I.

The devicemaker has reported 26 incidents, 16 injuries and no deaths related to the recall.

Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit

Advertisement

Next Up in Supply Chain

Advertisement

Comments are closed.