LILLIPUT D901 + ADAPTORSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033178100274), received between Oct 7, 2019 and Jan 25, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2022Leak/Splash; Leak/Splash

  SORIN GROUP (B)(6) RECEIVED A REPORT THAT, DURING PRIMING OF THE WATER COMPARTMENT, A LEAK WAS OBSERVED FROM THE LILLIPUT OXYGENATOR. DURING FOLLOW UP WITH THE CUSTOMER, SORIN GROUP (B)(6) HAS RECEIVED A VIDEO THAT DID NOT CLARIFY IF WATER ENTERED THE RESERVOIR WHEN PRIMING THE WATER SIDE OF LILLIPUT OXYGENATOR. THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13340623 ↗
• MalfunctionDec 1, 2021Blocked Connection; Blocked Connection

  SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, ARTERIAL BLOOD SAMPLE COULD NOT BE OBTAINED FROM THE ARTERIAL SAMPLING PORT OF TWO D901 LILLIPUT OXYGENATORS. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATORS. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909895 ↗
• MalfunctionOct 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  SEE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9160818 ↗