Maquet Cardiovascular, LLC recalls Acrobat-i Positioner. Model Number C-XP-5000Z

Recalled November 27, 2024 · FDA recall Z-0484-2025 · Maquet Cardiovascular

Hazard

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. · FDA Class II

Units

14,338 units

Sold at

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, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.

Description

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.

Product

Acrobat-i Positioner. Model Number C-XP-5000Z

Manufacturer(s)

Maquet Cardiovascular, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →