Device recall: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1…

Class I FDA enforcement event 87490. Recall start date: 3 Mar 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Medtronic Perfusion Systems started this device recall on 3 Mar 2021. The firm address in the FDA record is in Brooklyn Park, MN. FDA put the recall in Class I. FDA event 87490 has 1 product record. The first FDA enforcement report date is 7 Apr 2021. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico,…

Recalling firm

Medtronic Perfusion Systems, Brooklyn Park, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 87490: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1313-2021	Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.	387 devices (93 US)	Class I	Ongoing	7 Apr 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class I: 8%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 38

Other events of the firm

Other FDA enforcement events of Medtronic Perfusion Systems
Initiated	Product (first record)	Type	Class	Records
24 Jun 2026	EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return	Device	Class II	6
25 May 2026	Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula	Device	Class II	2
12 May 2026	Octopus Evolution Tissue Stabilizer, Model TS2000	Device	Class II	3
21 Apr 2026	Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular cat	Device	Class II	9
13 Jan 2026	Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1	Device	Class II	1
20 Oct 2025	Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03	Device	Class II	1
3 Oct 2025	MC3 VitalFlow Console, REF 58100; Blood pump of ecmo	Device	Class II	1
12 Sep 2025	Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B	Device	Class II	1
6 Aug 2025	DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113	Device	Class I	3
5 Feb 2025	Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR F	Device	Class I	1

Medtronic Perfusion Systems: all 38 events

Official channels

FDA enforcement report Z-1313-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 87490. https://recallregister.com/fda/i/87490/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico,…
What quantity of product is in FDA event 87490?: The FDA record gives this quantity: 387 devices (93 US)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 8% of the 900 device events that started in 2021 are in Class I.