OCS Liver System 3200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B00944705), received between Sep 9, 2025 and Nov 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Separation; Material Separation

  DURING INSTRUMENTATION OF A LIVER ON THE ORGAN CARE SYSTEM (OCS) IN THE DONOR OR, THE PORTAL VEIN (PV) AND HEPATIC ARTERY (HA) CONNECTORS BECAME LOOSE AND DETACHED FROM THE ORGAN CHAMBER, CAUSING BLOOD TO LEAK. ATTEMPTS TO REATTACH THE CONNECTORS WERE UNSUCCESSFUL. TEMPORARY MEASURES WERE APPLIED TO MAINTAIN INTEGRITY OF THE ORGAN CHAMBER AND THUS MAINTAIN STERILITY OF THE CIRCUIT. THE LIVER WAS ULTIMATELY DECLINED FOR TRANSPLANT. THIS EVENT IS BEING REPORTED UNDER ABUNDANCE OF CAUTION. INVESTIGATION SUMMARY: THE PERFUSION MODULE WAS EVALUATED AND THE ANALYSIS REVEALED THAT THE UV ADHESIVE USED TO SECURE THE HA/PV CONNECTORS WAS APPLIED IN THE CORRECT LOCATIONS; HOWEVER, THE APPLICATION QUALITY WAS POOR. THIS DEFECT LIKELY CONTRIBUTED TO CONNECTOR DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501294 ↗
• MalfunctionSep 9, 2025Mechanical Problem; Mechanical Problem

  DURING INSTRUMENTATION OF A LIVER ON THE OCS SYSTEM IN THE DONOR OR, A LEAK WAS IDENTIFIED AT THE HEPATIC ARTERY CONNECTOR, SPECIFICALLY AT THE JUNCTION WHERE THE WHITE PLASTIC COVER MEETS THE CONNECTOR BODY. THE LEAK WAS TEMPORARILY SEALED USING DERMABOND GLUE, ALLOWING PERFUSION TO RESUME AND THE ORGAN WAS SUBSEQUENTLY TRANSFERRED TO A NEW OCS LIVER SYSTEM PRIOR TO TRANSPORT TO THE RECIPIENT SITE. THE ORGAN WAS ULTIMATELY DECLINED FOR TRANSPLANT DUE TO CONCERNS OVER RISING LACTATE TRENDS (WHICH SUBSEQUENTLY STABILIZED) AND BIOPSY TIMING. BIOPSY RESULTS OBTAINED AFTER TURNDOWN SHOWED MINIMAL NECROSIS (5%), AND LACTATE LEVELS EVENTUALLY NORMALIZED. THE ABNORMAL LACTATE INCREASE FOLLOWING TRANSFER TO A NEW OCS WAS LIKELY A TRANSIENT REACTION INVESTIGATION SUMMARY: INSPECTION OF THE RETURNED HEPATIC ARTERY CONNECTOR REVEALED A LEAK FROM THE PRESSURE TRANSDUCERS WITHIN THE CONNECTOR. TWO COMPONENTS WITHIN THE TRANSDUCERS SEPARATED. THE ROOT CAUSE OF THE SEPARATION IS UNDER INVESTIGATION WITH (B)(4) SUPPLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005495 ↗