# FDA recall Z-0484-2025

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2024-10-16.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-0484-2025
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-16
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2025

## Citation

> AI Analytics. FDA recall Z-0484-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0484-2025. Source: US FDA. Licensed CC0.

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