Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

Recall date

August 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2961-2024

FDA classification

Class II

Brand / firm

Abiomed, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama,…

Why it was recalled

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;