Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (2021-03-05)

Revision D of recall: As a result of eight (8) customer complaints since revision A of this recall, a malfunction with the system controller module used in the Bio-Console 560 was identified. The malfunction is a result of the DC-DC converter and D88 diode failure because of a transient voltage spike in system controller module. This transient voltage spike has the potential to cause dielectric breakdown of the DC-DC converter front-end circuitry resulting in catastrophic failure/excessive current. Through 03-Jan-2022, this issue has resulted in eight (8) complaint occurrences (prior to use) where the instrument or user interface (UI) was not working (blank UI screen), error code 41 and/or smoking/smoking smell prior to use when the device was powered on. No adverse patient effects occurred as a result of these occurrences. Medtronic began using the affected PN in February 2021 to manufacture, service and implement part replacement per Technical Service Update (TSU) MOD0204. All Bio-Console 560 instruments manufactured (January & February 2021) with or had a system controller module installed with the affected system controller are affected by this issue. Additionally, system controller modules that are available for installation by the field service technicians for revision A of this recall are affected.

Recall start date: 2022-01-18