OCS Liver System 3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B00950480), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Infusion or Flow Problem; Infusion or Flow Problem

  EVENT DESCRIPTION THE OCS LIVER CONSOLE EXHIBITED AN ABNORMAL CLICKING NOISE DURING THE CASE, FOLLOWED BY A SUDDEN AND COMPLETE LOSS OF PUMP FLOW. ATTEMPTS TO INCREASE FLOW WERE UNSUCCESSFUL. THE DEVICE WAS RESET MULTIPLE TIMES, AND THE MODULE WAS REMOVED AND REINSTALLED. NORMAL FUNCTION WAS RESTORED AFTER REINSTALLATION. THE OCS FUNCTIONED NORMALLY AND THE LACTATE LEVELS TRENDED DOWN AND REMAINED LOW FOR REMAINDER OF THE CASE. THE INTERRUPTION LASTED APPROXIMATELY 21 MINUTES. THE LIVER WAS NOT TRANSPLANTED. BIOPSY FINDINGS INDICATED FOCAL APOPTOSIS - 10% FIBROSIS (STAGE 2- LEFT, STAGE 1- RIGHT), MACROSTEOTOSIS 30% (BOTH LOBES). APOPTOSIS MAY HAVE BEEN ASSOCIATED WITH THE REPORTED MALFUNCTION. INVESTIGATION SUMMARY THE REPORTED PUMP FAILURE WAS CONFIRMED. ROOT CAUSE ANALYSIS DETERMINED THAT THE FAILURE RESULTED FROM INADEQUATE ADHESION OF THE RETAINING COMPOUND BETWEEN THE BALL SCREW AND THE MOTOR SHAFT. THIS CONDITION ALLOWED THE BALL SCREW TO ROTATE FREELY, PREVENTING PROPER PUMP OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560410 ↗