LILLIPUT D902Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033178100304), received between Aug 24, 2017 and Apr 18, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Coagulation in Device or Device Ingredient; Unexpected Therapeutic Results; Coagulation in Device or Device Ingredient; Unexpected Therapeutic Results

  SEE INITIAL REPORT.

  Patient problems: Arrhythmia; Ventricular Fibrillation

  MAUDE report 21864998 ↗
• MalfunctionMay 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, (B)(4) HAS RECEIVED A REPORT THAT DURING PRIMING, THE VENOUS RESERVOIR FILLED WITH WATER. DURING FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS CLARIFIED THAT THE ISSUE WAS IDENTIFIED FEW MINUTES AFTER STARTING RECIRCULATING WATER IN THE LILLIPUT OXYGENATOR CONNECTED WITH THE HEATER-COOLER. ON (B)(6), IT WAS CLARIFIED THAT THE WATER WAS IN THE RESERVOIR UP TO THE ROLLER. THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893895 ↗
• MalfunctionJun 29, 2018Leak/Splash; Low Readings; Device Operational Issue; Leak/Splash; Low Readings; Device Operational Issue

  SORIN GROUP ITALIA RECEIVED A REPORT THAT THE PO2 VALUES DROPPED TO 43.6 MMHG AND BLOOD DROPLETS WERE NOTICED COMING OUT FROM THE LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR GAS VENT PORT 10 MINUTES INTO A PROCEDURE. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, THE PATIENT DEVELOPED SEPSIS AND THE ICU STAY WAS PROLONGED 14 DAYS.

  Patient problems: Sepsis

  MAUDE report 7649500 ↗
• MalfunctionAug 24, 2017Fluid/Blood Leak; Device Operational Issue; Fluid/Blood Leak; Device Operational Issue

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT A BLOOD TO WATER LEAKAGE OCCURRED IN A LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR DURING A PROCEDURE. A NEW OXYGENATOR COULD NOT BE PRIMED DUE TO THE UNAVAILABILITY OF BLOOD SO THE PATIENT TEMPERATURE WAS RECOVERED USING A HEATER COOLER AND BLANKET. THIS REPORTEDLY TOOK 2 HOURS. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816109 ↗