Maquet Cardiovascular, LLC 2024-11-27 Health serious FDA
Health · FDA · Recall #FDA-Z-0486-2025
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z Recall
Issued November 27, 2024 · Maquet Cardiovascular, LLC
In November 2024, Maquet Cardiovascular, LLC recalled the Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Maquet Cardiovascular, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Maquet Cardiovascular, LLC
- Category
- Health
- Recall date
- November 27, 2024
- Units affected
- Not reported
- Sold at
- Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzego
- Recall number
- FDA-Z-0486-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Maquet Cardiovascular, LLC has 7 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.