Maquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

Recall date

August 15, 2025

Source

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

Recall number

Z-2587-2025

FDA classification

Class II

Brand / firm

Maquet Cardiovascular, LLC

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, S…

Why it was recalled

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

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

What was recalled

Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.