# FDA recall Z-0646-2018

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2018-01-16.

## Product

Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T  The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.

## Reason for recall

Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.

## Distribution

Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and  United Kingdom.

## Key facts

- **Recall number:** Z-0646-2018
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-16
- **Report date:** 2018-02-28
- **Termination date:** 2020-08-21

- **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-0646-2018

## Citation

> AI Analytics. FDA recall Z-0646-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0646-2018. Source: US FDA. Licensed CC0.

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