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OrganOx metra

ORGANOX LIMITED · Model D0146 · UDI-DI 05060462240029

QQK Prescription

510(k) clearances

538

Adverse events (3 deaths)

Recalls

Facilities

Description

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

Recalls

Date	Firm	Reason
2024-10-15	OrganOx Ltd	Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.