# FDA recall Z-1313-2021

> **Medtronic Perfusion Systems** · Class I · device recall initiated 2021-03-03.

## Product

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers:  560BC, 560BC1, 560BCS, 560BCS1, R560BCS1.  Used in cardiopulmonary bypass (CPB) procedures.

## Reason for recall

An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping.  Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.

## Distribution

Worldwide distribution.  US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico, Morocco, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, and Viet Nam

## Key facts

- **Recall number:** Z-1313-2021
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-03
- **Report date:** 2021-04-07

- **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-1313-2021

## Citation

> AI Analytics. FDA recall Z-1313-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1313-2021. Source: US FDA. Licensed CC0.

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