Perfusion Pack (UDI 00803622133909)Recalls & reported problems
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00803622133909), received between Jul 25, 2023 and Jun 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Unexpected Therapeutic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
OXYGENATOR FAILED AS CPB WAS INITIATED. PREBYPASS O2 CHECKS WERE ALL NORMAL. BLENDER, FLOWMETER, AND OXYGEN SENSOR WERE ALL REGISTERING NORMAL O2 LEVELS. IMMEDIATELY UPON INITIATION OF BYPASS, PERFUSIONIST NOTICED DARK BLOOD WITH FIO2 SETTING AT 100%. PERFUSIONIST TRACED THE GAS FLOW LINE, NO LEAKS OR OBSTRUCTIONS WERE FOUND. PERFUSIONIST CALLED FOR BACKUP. 3 PERFUSIONISTS TROUBLESHOOTED AND COULD NOT FIND ANY ISSUES WITH GAS FLOW TO THE OXYGENATOR. IT WAS THEN DECIDED TO CHANGE OUT THE OXYGENATOR. THEY CAME OFF OF CPB FOR A FEW MINUTES WHILE ANESTHESIA VENTILATED THE PATIENT AND THEY CHANGED OUT THE OXYGENATOR. AS SOON AS BYPASS WAS RE-INITIATED, BRIGHT RED BLOOD WAS OBSERVED AND NEW OXYGENATOR WAS WORKING EFFICIENTLY. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296120 ↗MalfunctionJul 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
LIVANOVA USA RECEIVED A REPORT THAT A PUMP BOOT TUBING SPLIT DURING THE CASE. THEY WERE ALMOST OFF BYPASS AND WERE ABLE TO COME OFF . THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17425357 ↗MalfunctionJul 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
LIVANOVA USA HAS RECEIVED A REPORT THAT, NEARLY AT THE END OF A PORCEDURE, ARTERIAL TUBING SPLIT (LIVANOVA TUBING PACK) AND BLOOD WAS LEAKING. PATIENT WAS NOT AFFECTED BY THE MINIMAL BLOOD LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17387109 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.