Maquet Cardiovascular, LLC recalls Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

Recall date

October 16, 2024

Source

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

Recall number

Z-0485-2025

FDA classification

Class II

Brand / firm

Maquet Cardiovascular, LLC

Sold / distributed

Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembo…

Why it was recalled

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

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

What was recalled

Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z