Medical Device Recall: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Maquet Cardiovascular, LLC · October 16, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
33,823 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0486-2025
Status: ongoing
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