OCS Heart System 1200Recalls & reported problems
Transmedics, Inc. · OCS Heart Perfusion Set · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B00948225), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Leak/Splash; Leak/Splash
DURING THE PRIMING OF A PERFUSION MODULE IN PREPARATION FOR A DCD HEART TRANSPLANT ON (B)(6) 2025, A RAPID AND SIGNIFICANT LEAK WAS OBSERVED ORIGINATING FROM THE BLOOD WARMER PREVENTING FLOW INTO THE AORTIC TUBING. AS A RESULT, THE PERFUSION MODULE COULD NOT BE USED, AND THE HEART COULD NOT BE PRESERVED ON THE OCS. THIS EVENT IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION. THE MALFUNCTION WAS IDENTIFIED PRIOR TO INSTRUMENTING THE ORGAN ON THE OCS SYSTEM. INVESTIGATION SUMMARY: THE RETURNED PERFUSION MODULE EXHIBITED A SIGNIFICANT LEAK AT THE JUNCTION BETWEEN THE PLASTIC AND ALUMINUM COMPONENTS OF THE BLOOD WARMER. LEAK TESTING CONFIRMED THE FAILURE, AND VISUAL INSPECTION REVEALED THAT THE INTERNAL O-RING WAS NOT FULLY SEATED IN ITS CHANNEL, CREATING A GAP THAT ALLOWED FLUID TO ESCAPE. THE ISSUE WAS DETERMINED TO BE AN ISOLATED ISSUE WHERE THE LEAK TEST DIDN'T IDENTIFY MANUFACTURING ERROR, WITH NO PRIOR OCCURRENCES IN OVER 10,000 OCS CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22864349 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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