Recall Z-1313-2021— Medtronic Perfusion Systems

Name: FDA recall Z-1313-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-03

Class I · Ongoing

Class I FDA medical device recall by Medtronic Perfusion Systems, initiated 2021-03-03. It names one FDA 510(k) clearance: K131964. Product: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.. Reason: 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..

Recalling firm: Medtronic Perfusion Systems
Classification: Class I
Status: Ongoing
Initiated: 2021-03-03
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLEMedtronic, Inc.·cleared 2013-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.