Agency classClass IOur severity:Severe FDA (Devices)·Z-1313-2021·Announced 2021-04-07

Medtronic Bio-Console 560 Blood Pumping Console Recalled for Electrical Failure

Medtronic is recalling Bio-Console 560 devices because an electrical component may fail, causing the pump to stop and potentially producing smoke or a burning odor.

The agency’s classification

FDA (Devices): Class I

Class I is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device used in life-sustaining procedures where failure could lead to serious injury or death, and the source explicitly mentions smoking and burning odors, indicating a significant hazard.

Plain-English summary

Medtronic Perfusion Systems is recalling 387 Bio-Console 560 Extracorporeal Blood Pumping Consoles, including models 560BC, 560BC1, 560BCS, 560BCS1, and R560BCS1. These devices are used in cardiopulmonary bypass (CPB) procedures. The recall affects 93 units in the United States and includes worldwide distribution to numerous other countries.

The recall is due to a potential electrical failure in the system controller module. This failure may cause the device to stop pumping, the user interface to go blank, and the device to smoke or produce a burning odor during use.

Healthcare facilities should identify affected devices by checking the serial numbers listed in the official recall notice. Users should stop using the affected devices and contact Medtronic Perfusion Systems for instructions on repair or replacement.

The recalled product

Product: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Cardiopulmonary Bypass
Hazard: electrical-failure
fire
burn-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

560BC: GTIN 00885074539386
Serial Numbers: 560B100094
560B100212
560B100244
560B100257
560B100274
560B100283
560B100418
560B100439
560B100482 560BC1: GTIN 00613994450326
Serial Numbers: 560B100901
560B101368 560BCS: GTIN 00613994258236
Serial Numbers: 560B100369
560B100376
560B100472
560B100495
560B100496 560BCS1: GTIN: 00613994450463
Serial Numbers: 560B100191
560B100690
560B100783

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Medtronic Perfusion Systems

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