# FDA recall Z-1192-2021

> **Medtronic Perfusion Systems** · Class I · device recall initiated 2021-02-04.

## Product

Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR).  The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is  a single-use device designed to collect and store blood during extracorporeal  circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing  with the venous blood, which is filtered. The primary blood-contacting surfaces  of the CVR are coated with Balance Biosurface to reduce platelet activation and  adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

## Reason for recall

Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

## Distribution

Worldwide distribution: US nationwide, Afghanistan,  Argentina,  Chile,  China,  Colombia,  Egypt,  Germany,  Iraq,  Italy,  Japan,  Korea,  Kyrgyzstan,  Latvia,  Nicaragua,  Paraguay,  Poland,  Qatar,  Romania,  Tanzania,  United Arab Emirates,  United Kingdom,  Uzbekistan, and Viet Nam

## Key facts

- **Recall number:** Z-1192-2021
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-04
- **Report date:** 2021-03-24
- **Termination date:** 2024-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn Park, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1192-2021

## Citation

> AI Analytics. FDA recall Z-1192-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1192-2021. Source: US FDA. Licensed CC0.

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